Surgical Direct

FDA UDI

Class II (US FDA UDI)

by Surgical Direct, Inc.

Identity

Trade Name: Surgical Direct FDA UDI
Generic Name: Flexible endoscopic biopsy forceps, reusable FDA UDI
Device Name: 1mm x 14cm Long Oval Biopsy Forceps, Custom Length, Ring Style Handle FDA UDI
Model / Reference: SD86501412 FDA UDI
Description: 1mm x 14cm Long Oval Biopsy Forceps, Custom Length, Ring Style Handle FDA UDI

Identifiers

Catalog Number: SD86501412 FDA UDI
Primary DI / UDI-DI: B382SD865014120 FDA UDI
FDA Product Code: GCJ FDA UDI
GMDN Term: Flexible endoscopic biopsy forceps, reusable 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Flexible endoscopic biopsy forceps, reusable

Surgical Direct by Surgical Direct, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible endoscopic biopsy forceps, reusable.

Laryngoscopy Forceps — SONTEC INSTRUMENTS, INC. · Class I
STRATTE SCISSORS — SONTEC INSTRUMENTS, INC. · Class I
ELMED INCORPORATED — ELMED INCORPORATED · Class I
Laryngoscopy Forceps — SONTEC INSTRUMENTS, INC. · Class I
BX Series Reusable Biopsy Forceps — Primed Instruments Inc · Class I
LARYNGOSCOPY ALLIGATOR FORCEPS — SONTEC INSTRUMENTS, INC. · Class I
MicroFrance® — Integra Microfrance · Class I
Biopsy Forceps, Blakesley — Joimax GmbH · 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 II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Surgical Direct, Inc.

Sources (1)

FDA UDI 97cc3ed0-e9a4-4e0b-ab3b-222068191976 35 fields · synced Jun 8, 2026