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SubQ It!

FDA UDI

Class II (US FDA UDI)

by Opus Ksd, Inc.

Identity

Trade Name
SubQ It! FDA UDI
Generic Name
Skin stapler/staple, bioabsorbable FDA UDI
Device Name
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. FDA UDI
Model / Reference
SF10 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
408010 FDA UDI
Primary DI / UDI-DI
00867469000213 FDA UDI
510(k) Number
K131563 FDA UDI
FDA Product Code
GDW FDA UDI
GAG FDA UDI
GMDN Term
Skin stapler/staple, bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4750 FDA UDI
878.4740 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Skin stapler/staple, bioabsorbable

SubQ It! by Opus Ksd, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Skin stapler/staple, bioabsorbable.

Cleared under the same submission

K131563 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Opus Ksd, Inc.

Sources (1)

  • FDA UDI d1263f9d-2761-458e-aea0-3201ee36954a 37 fields · synced May 30, 2026