Duns Number:801895244
Device Description: INSORB Subcuticular Skin Stapler REF1008 (each)
Catalog Number
REF1008
Brand Name
INSORB
Version/Model Number
1008
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GAG
Product Code Name
Stapler, Surgical
Public Device Record Key
f38b0375-d582-4d35-8334-14b26da7655d
Public Version Date
September 10, 2021
Public Version Number
5
DI Record Publish Date
September 14, 2016
Package DI Number
10867516000118
Quantity per Package
12
Contains DI Package
00867516000111
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |