| Human Cell, Tissue or
Cellular or Tissue-Based Product (HCT/P)
|
Select
Yes if the product contains human
cell or tissue to use in implants, transplants, infusions, or to transfer to a
human recipient as defined in 21 CFR 1271.3. Otherwise, select
No. If you select
Yes, you must create a market
authorization object.
|
| Kit
|
Select
Yes if the product is a convenience,
combination, or in-vitro diagnostic, or medical procedure kit. Otherwise,
select
No. If you select
No, you must create a market
authorization object.
|
| Combination
Product
|
Select
Yes if the product contains multiple
regulated products packaged together as defined in 21 CFR 3.2(e). Otherwise,
select
No.
|
| Product Code
|
Type the three-letter classification
code issued by the regulatory authority for premarket devices. Click
 to add another product code.
|
| FDA Listing
Number
|
Type the listing number assigned by FDA
to devices in commercial distribution irrespective of the premarket
authorization requirements defined in 21 CFR 807.28(f). Click
to add another listing number.
|
| GMDN Code
|
Type the five-digit Global Medical
Device Nomenclature (GMDN) code. Click
to add another GMDN code.
|
| Device Exempt from Premarket
Submission
|
Select
Yes if the device is exempt from
premarket submission or it is a preamendment device. Otherwise, select
No. If you select
No, you must create a market
authorization object.
|