| For Single-Use
|
Select
TRUE if the device is intended to be
used for one time only. Otherwise, select
FALSE.
|
| Production
Identifier
|
Select the identifiers that are used in
the production of the device. It has the below values:
- Expiration Date
- Lot or Batch Number
- Manufacturing Date
- Serial Number
- Software Indication. This option is available for
the device that is created in EU.
|
| Device required to be
labeled as containing natural rubber latex or dry natural rubber (21 CFR
801.437)
|
Select
Yes if the product or its packaging
contains natural rubber as defined in 21 CFR 801.437. Otherwise, select
No.
|
| Device labeled with "Not
made with natural rubber latex"
|
Select
Yes if the product or its packaging
does not contain natural rubber. Otherwise, select
No.
|
| Prescription Use
(Rx)
|
Select
Yes if a prescription is required to
purchase the product. Otherwise, select
No.
|
| Over the Counter
(OTC)
|
Select
Yes if a prescription is not
required to purchase the product. Otherwise, select
No.
|
| Is the device labeled for
MRI safety?
|
Select
Yes if the device is tested to use
in an MRI environment. Otherwise, select
No.
|
| MRI Safety
Status
|
Select the status of the MRI safety
testing. You can select MR Conditional, MR Safe, or MR UnSafe. You must select
a status if you select
Yes in the
Is the device labeled for MRI
safety? field.
|
| Device Packaged as
Sterile
|
Select
Yes if the device is sterilized.
Otherwise, select
No.
|
| Requires Sterilization Prior
to Use
|
Select
Yes if the device must be sterilized
before use. Otherwise, select
No.
|
| Sterilization
Method
|
Select the sterilization method that
must be performed on the device before use. You must select a sterilization
method if you select
Yes in the
Requires Sterilization Prior to Use
field.
|