Bosma Enterprises

FDA UDI

Class I (US FDA UDI)

by Bosma Enterprises

Identity

Trade Name: Bosma Enterprises FDA UDI
Generic Name: Surgical linen/cushion set FDA UDI
Device Name: Accelerate-OR OM Kit; Each Kit Includes QuickSuite Kit and 4x60 Foam Positioning Strap. FDA UDI
Model / Reference: 10-8020OM FDA UDI
Description: Accelerate-OR OM Kit; Each Kit Includes QuickSuite Kit and 4x60 Foam Positioning Strap. FDA UDI

Identifiers

Catalog Number: 10-8020OM FDA UDI
Primary DI / UDI-DI: 00818634020598 FDA UDI
FDA Product Code: PWU FDA UDI
GMDN Term: Surgical linen/cushion set FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6890 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

Yes

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: Limb/torso/head restraint, single-use Surgical linen/cushion set

Bosma Enterprises by Bosma Enterprises — 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: Bosma Enterprises

Sources (1)

FDA UDI b02c0d65-e5c0-4990-8848-c4ce851f6734 36 fields · synced May 30, 2026