Brasseler USA

FDA UDI

Class I (US FDA UDI)

by Peter Brasseler Holdings, LLC

Identity

Trade Name: Brasseler USA FDA UDI
Generic Name: Rubber dam clamp FDA UDI
Device Name: 76D-12A RUBBER DAM CLAMP 1P FDA UDI
Model / Reference: 5014498U0 FDA UDI
Description: 76D-12A RUBBER DAM CLAMP 1P FDA UDI

Identifiers

Primary DI / UDI-DI: 00887919589433 FDA UDI
FDA Product Code: EEF FDA UDI
GMDN Term: Rubber dam clamp FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6300 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

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Rubber dam clamp

Brasseler USA by Peter Brasseler Holdings, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rubber dam clamp.

Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
SCOTT'S SELECT RUBBER DAM CLAMP # 203 — SCOTT'S DENTAL SUPPLY L.L.C. · Class I
Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
SCOTT'S SELECT RUBBER DAM CLAMP # 202 — SCOTT'S DENTAL SUPPLY L.L.C. · Class I
BL Clamp — B&L Biotech Co., Ltd. · Class I
Power Dental U.S.A., Inc. — Power Dental USA, Inc. · Class I
Hygenic — Coltene/Whaledent Inc. · Class I
Power Dental U.S.A., Inc. — Power Dental USA, Inc. · 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

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

Manufacturer

Manufacturer: Peter Brasseler Holdings, LLC

Sources (1)

FDA UDI 865654ba-81b6-49e4-862a-2cc1756d71b0 33 fields · synced Jun 8, 2026