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OTSC Anchor

FDA UDI

Class II (US FDA UDI)

by Ovesco Endoscopy AG

Identity

Trade Name
OTSC Anchor FDA UDI
Generic Name
Flexible endoscopic tissue manipulation forceps, single-use FDA UDI
Device Name
The OTSC Anchor is one of the OTSC application aids • can be used for treating a lesion before release of the OTSC clip • can be used for better approximation of tissue especially when indurated (e.g. fistulae, chronic ulcer) • facilitates targeting lesions, e.g. in the treatment of hemorrhage • allows precise alignment between the target tissue and the application cap • the head of the instrument is made of Nitinol • a working channel diameter of at least 3.2 mm is required when used in combination with the OTSC System FDA UDI
Model / Reference
165 cm FDA UDI
Description
The OTSC Anchor is one of the OTSC application aids • can be used for treating a lesion before release of the OTSC clip • can be used for better approximation of tissue especially when indurated (e.g. fistulae, chronic ulcer) • facilitates targeting lesions, e.g. in the treatment of hemorrhage • allows precise alignment between the target tissue and the application cap • the head of the instrument is made of Nitinol • a working channel diameter of at least 3.2 mm is required when used in combination with the OTSC System FDA UDI

Identifiers

Catalog Number
200.10 FDA UDI
Primary DI / UDI-DI
04260206310143 FDA UDI
FDA Product Code
PTS FDA UDI
GMDN Term
Flexible endoscopic tissue manipulation forceps, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Flexible endoscopic tissue manipulation forceps, single-use

OTSC Anchor by Ovesco Endoscopy AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible endoscopic tissue manipulation forceps, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ovesco Endoscopy AG

Sources (1)

  • FDA UDI 23cc0847-bd15-474b-825f-7d4da538ef11 36 fields · synced May 30, 2026