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DuraClip(TM) Repositionable Hemostasis Clip

FDA UDI

Class II (US FDA UDI)

by Transmed (China) Co., Ltd.

Identity

Trade Name
DuraClip(TM) Repositionable Hemostasis Clip FDA UDI
Generic Name
Gastrointestinal endoscopic clip, short-term FDA UDI
Device Name
Open width11±1mm the max OD of insertion part 2.6mm working length 1650mm coated FDA UDI
Model / Reference
DC0165 FDA UDI
Description
Open width11±1mm the max OD of insertion part 2.6mm working length 1650mm coated FDA UDI

Identifiers

Catalog Number
DC0165 FDA UDI
Primary DI / UDI-DI
16932619740026 FDA UDI
FDA Product Code
PKL FDA UDI
GMDN Term
Gastrointestinal endoscopic clip, short-term FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4400 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Gastrointestinal endoscopic clip, short-term

DuraClip(TM) Repositionable Hemostasis Clip by Transmed (China) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gastrointestinal endoscopic clip, short-term.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Transmed (China) Co., Ltd.

Sources (1)

  • FDA UDI 7925033c-70c7-4ab2-812c-1e2c053a8ef8 34 fields · synced May 30, 2026