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AbClose

FDA UDI

Class I (US FDA UDI)

by Medeon Biodesign, Inc.

Identity

Trade Name
AbClose FDA UDI
Generic Name
Gastrointestinal endoscopic clip, long-term, non-bioabsorbable FDA UDI
Device Name
The AbClose Port Site Closure Device includes the following components: • One (1) Suture Passer • One (1) Suture Guide The AbClose - Port Site Closure Device is a sterile, single-use device, which includes one Suture Guide and one Suture Passer. The Suture Guide has two channels to direct the Suture Passer with suture strand into the Suture Catcher. The Suture Catcher grasps the end of the suture strand. By withdrawing the Suture Guide from the abdominal cavity after the sutures are deployed, the device automatically creates a loop for closure. At the end, any standard knot tying technique may be performed by the physician to close the incision. FDA UDI
Model / Reference
M12 Rev.V24 FDA UDI
Description
The AbClose Port Site Closure Device includes the following components: • One (1) Suture Passer • One (1) Suture Guide The AbClose - Port Site Closure Device is a sterile, single-use device, which includes one Suture Guide and one Suture Passer. The Suture Guide has two channels to direct the Suture Passer with suture strand into the Suture Catcher. The Suture Catcher grasps the end of the suture strand. By withdrawing the Suture Guide from the abdominal cavity after the sutures are deployed, the device automatically creates a loop for closure. At the end, any standard knot tying technique may be performed by the physician to close the incision. FDA UDI

Identifiers

Catalog Number
M12 FDA UDI
Primary DI / UDI-DI
04719872920328 FDA UDI
FDA Product Code
HCF FDA UDI
GCJ FDA UDI
OCW FDA UDI
GMDN Term
Gastrointestinal endoscopic clip, long-term, non-bioabsorbable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
876.1500 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

Yes

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

No

FDA UDI

Category: Gastrointestinal endoscopic clip, long-term, non-bioabsorbable

AbClose by Medeon Biodesign, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gastrointestinal endoscopic clip, long-term, non-bioabsorbable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medeon Biodesign, Inc.

Sources (1)

  • FDA UDI 257dcf50-6ad7-4824-b6ec-a08a5ad59d94 35 fields · synced Jun 1, 2026