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Bell-Horn

FDA UDI

Class I (US FDA UDI)

by Djo, Llc

Identity

Trade Name
BELL-HORN FDA UDI
Generic Name
Single-chamber venous compression system garment, reusable FDA UDI
Device Name
MASTECTOMY ARMSLEEVE 20-30MMHG, M FDA UDI
Model / Reference
99100M FDA UDI
Description
MASTECTOMY ARMSLEEVE 20-30MMHG, M FDA UDI

Identifiers

Primary DI / UDI-DI
00888912510639 FDA UDI
FDA Product Code
MHW FDA UDI
GMDN Term
Single-chamber venous compression system garment, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.5075 FDA UDI
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

No

FDA UDI

Over-the-Counter

Yes

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Single-chamber venous compression system garment, reusable

Bell-Horn by Djo, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Single-chamber venous compression system garment, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Djo, Llc

Sources (1)

  • FDA UDI 8e53c74b-a29e-4e20-9cff-eeae942ee8a4 33 fields · synced Jun 1, 2026