Primo

FDA UDI

Class I (US FDA UDI)

by Asp Global, LLC

Identity

Trade Name: PRIMO FDA UDI
Generic Name: Traction boot FDA UDI
Device Name: BUCK'S TRACTION BOOT, PURPLE, 10EA/CS FDA UDI
Model / Reference: BT01 FDA UDI
Description: BUCK'S TRACTION BOOT, PURPLE, 10EA/CS FDA UDI

Identifiers

Primary DI / UDI-DI: 00840216120624 FDA UDI
FDA Product Code: FMP FDA UDI
GMDN Term: Traction boot 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

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Traction boot

Primo by Asp Global, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Traction boot.

Active Heel Traction Boot — Smith & Nephew, Inc. · Class I
Paradigm Revolution — Conmed Corporation · Class I
ADANTE TRACTION BOOT, EX LARGE, PAIR — Mizuho Orthopedic Systems, Inc. · Class I
SPLINT, UNIVERSAL BUCK'S TRACTION — Mizuho Orthopedic Systems, Inc. · Class I
Active Heel Traction Boot — Smith & Nephew, Inc. · Class I
Active Heel Traction Boot — Smith & Nephew, Inc. · Class I
Active Heel Traction Boot — Smith & Nephew, Inc. · Class I
Arthrex® — Arthrex, Inc. · Class I

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Asp Global, LLC

Sources (1)

FDA UDI fab28e20-bd6b-44a7-a54b-7ebc27dd1267 33 fields · synced May 30, 2026