PRIMOBoot, Gray/Navy - Standard

FDA UDI

Class I (US FDA UDI)

by Primo Inc

Identity

Trade Name: PRIMOBoot, Gray/Navy - Standard FDA UDI
Generic Name: Heel protector FDA UDI
Device Name: BAB7 PRIMOBoot, Burn - Standard 13/each; BAB7W PRIMOBoot w/wedge, Burn - Standard 8/each FDA UDI
Model / Reference: BAB7 FDA UDI
Description: BAB7 PRIMOBoot, Burn - Standard 13/each; BAB7W PRIMOBoot w/wedge, Burn - Standard 8/each FDA UDI

Identifiers

Catalog Number: BAB7, BAB7W FDA UDI
Primary DI / UDI-DI: 00810006681055 FDA UDI
FDA Product Code: FMP FDA UDI
GMDN Term: Heel protector FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6450 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

Category: Heel protector

PRIMOBoot, Gray/Navy - Standard by Primo Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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

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Manufacturer

Manufacturer: Primo Inc

Sources (1)

FDA UDI e98537a2-85d5-467d-bb54-fc7b56bfc569 34 fields · synced May 30, 2026