Duns Number:965571289
Device Description: SubQ It! Bioabsorbable Skin Closure SF10 is a single-patient use, skin stapler preloaded w SubQ It! Bioabsorbable Skin Closure SF10 is a single-patient use, skin stapler preloaded with 10 bioabsorbable fasteners, packaged and sterilized individually in a protective foil pouch.
Catalog Number
408010
Brand Name
SubQ It!
Version/Model Number
SF10
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"
-
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
K131563,K131563
Product Code
GAG
Product Code Name
Stapler, Surgical
Public Device Record Key
d1263f9d-2761-458e-aea0-3201ee36954a
Public Version Date
March 10, 2021
Public Version Number
3
DI Record Publish Date
July 29, 2019
Package DI Number
10867469000210
Quantity per Package
10
Contains DI Package
00867469000213
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelf Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |