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Breg

FDA UDI

Class I (US FDA UDI)

by Breg, Inc.

Identity

Trade Name
BREG FDA UDI
Generic Name
General surgical procedure kit, non-medicated, single-use FDA UDI
Model / Reference
DRESSING SHLDR XL FDA UDI

Identifiers

Catalog Number
04918 FDA UDI
Primary DI / UDI-DI
00672736015261 FDA UDI
FDA Product Code
KGX FDA UDI
GMDN Term
General surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.5240 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: General surgical procedure kit, non-medicated, single-use

Breg by Breg, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Breg, Inc.

Sources (1)

  • FDA UDI da426413-b301-4ccc-81f2-5b9e91b271ce 34 fields · synced May 30, 2026