Heel/Elbow Protector

FDA UDI

Class I (US FDA UDI)

by Primo Inc

Identity

Trade Name: Heel/Elbow Protector FDA UDI
Generic Name: Arm friction/impact protector FDA UDI
Device Name: Heel/Elbow Protector - Large (knitted w/foam) FDA UDI
Model / Reference: HEP01L FDA UDI
Description: Heel/Elbow Protector - Large (knitted w/foam) FDA UDI

Identifiers

Catalog Number: HEP01L FDA UDI
Primary DI / UDI-DI: 00810006681833 FDA UDI
FDA Product Code: FMP FDA UDI
GMDN Term: Arm friction/impact 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: Arm friction/impact protector

Heel/Elbow Protector 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 a5956cdb-4681-4c76-b2e9-0d6a2b706ef0 34 fields · synced Jun 1, 2026