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Brasseler USA

FDA UDI

by Peter Brasseler Holdings, LLC

Identity

Trade Name
Brasseler USA FDA UDI
Generic Name
Diamond dental bur, single-use FDA UDI
Device Name
CSI KITS 8601-T3600S 1P FDA UDI
Model / Reference
5027381U0 FDA UDI
Description
CSI KITS 8601-T3600S 1P FDA UDI

Identifiers

Primary DI / UDI-DI
00887919839965 FDA UDI
GMDN Term
Diamond dental bur, single-use FDA UDI

Classification

Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Diamond dental bur, single-use

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

Similar devices

Also classified as Diamond dental bur, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Peter Brasseler Holdings, LLC

Sources (1)

  • FDA UDI 89c585c7-e886-4a31-8fcb-a6e782f10855 33 fields · synced May 29, 2026