OptiBite Disposable Biopsy Forceps

FDA UDI

Class I (US FDA UDI)

by Micro-Tech (Nanjing) Co., Ltd.

Identity

Trade Name: OptiBite Disposable Biopsy Forceps FDA UDI
Generic Name: Rigid endoscopic biopsy forceps, single-use FDA UDI
Device Name: Normal handle, Alligator, without spike, Single outer sheath, FEP coated, Two Wire, 2.3*2300 mm FDA UDI
Model / Reference: 100576 FDA UDI
Description: Normal handle, Alligator, without spike, Single outer sheath, FEP coated, Two Wire, 2.3*2300 mm FDA UDI

Identifiers

Catalog Number: 100576 FDA UDI
Primary DI / UDI-DI: 06932503540360 FDA UDI
FDA Product Code: FCL FDA UDI
GMDN Term: Rigid endoscopic biopsy forceps, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.1075 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 230 Centimeter FDA UDI
Lumen/Inner Diameter — 2.8 Millimeter FDA UDI

Category: Rigid endoscopic biopsy forceps, single-use

OptiBite Disposable Biopsy Forceps by Micro-Tech (Nanjing) Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rigid endoscopic biopsy forceps, single-use.

THD BIOPSY — THD SPA · Class I
LiNA OperaScope™ Biopsy Forceps — Lina Medical ApS · Class I
REDPINE — Guangzhou Red Pine Medical Instrument Co., Ltd. · Class I
HERizon Disposable Endoscopic Forceps - Inverted Tooth — MINERVA SURGICAL, INC. · Class I
EVONOS — Gyrus Acmi, Inc. · Class I
HERizon Disposable Endoscopic Forceps – Alligator — MINERVA SURGICAL, INC. · Class I
THD BIOPSY — THD SPA · Class I
THD BIOPSY — THD SPA · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Micro-Tech (Nanjing) Co., Ltd.

Sources (1)

FDA UDI d2325e72-b503-49e9-9931-d8ec2e9e3856 36 fields · synced May 30, 2026