RePlay

FDA UDI

Class II (US FDA UDI)

by Diversatek Healthcare

Identity

Trade Name: RePlay FDA UDI
Generic Name: Gastrointestinal endoscopic clip, short-term FDA UDI
Device Name: RePlay Hemostasis Clip, 11mm span FDA UDI
Model / Reference: 1170-01 FDA UDI
Description: RePlay Hemostasis Clip, 11mm span FDA UDI

Identifiers

Catalog Number: 1170-01 FDA UDI
Primary DI / UDI-DI: 00816734021484 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 230 Centimeter FDA UDI
Outer Diameter — 2.3 Millimeter FDA UDI
Width — 11 Millimeter FDA UDI

Category: Gastrointestinal endoscopic clip, short-term

RePlay by Diversatek Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gastrointestinal endoscopic clip, short-term.

ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
Disposable Hemostatic Clips — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
DuraClip(TM) Repositionable Hemostasis Clip — Transmed (China) Co., Ltd. · Class II
Disposable Hemostatic Clips — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
Disposable Hemostatic Clips — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
Disposable Hemostatic Clips — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
Disposable Hemostatic Clips — Ningbo Xinwell Medical Technology Co., Ltd. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Diversatek Healthcare

Sources (1)

FDA UDI d750cfec-2ec3-4c03-aa05-44d4db217385 37 fields · synced May 30, 2026