Duns Number:965571289
Device Description: SubQ It! Bioabsorbable Skin Closure System consists of a single-patient use, disposable st SubQ It! Bioabsorbable Skin Closure System consists of a single-patient use, disposable stapler preloaded with 10 bioabsorbable fasteners, packaged and sterilized individually in a protective foil pouch.
Catalog Number
-
Brand Name
SubQ It!
Version/Model Number
404010
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
32f021bc-02b6-4098-9d0b-a5ab76609103
Public Version Date
August 06, 2019
Public Version Number
4
DI Record Publish Date
August 30, 2016
Package DI Number
10867469000203
Quantity per Package
10
Contains DI Package
00867469000206
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 |