BOSS Instruments

FDA UDI

Class I (US FDA UDI)

by Boss Instruments, Ltd.

Identity

Trade Name: BOSS Instruments FDA UDI
Generic Name: Ligature loop applier FDA UDI
Device Name: Rumel Tourniquets, flex-neck, adult, 12" FDA UDI
Model / Reference: 66-1550 FDA UDI
Description: Rumel Tourniquets, flex-neck, adult, 12" FDA UDI

Identifiers

Catalog Number: 66-1550 FDA UDI
Primary DI / UDI-DI: 00888515117280 FDA UDI
FDA Product Code: DWS FDA UDI
GMDN Term: Ligature loop applier FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 870.4500 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

Yes

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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Ligature loop applier

BOSS Instruments by Boss Instruments, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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BOSS Instruments — Boss Instruments, Ltd. · Class I
BOSS Instruments — Boss Instruments, Ltd. · Class I
BOSS Instruments — Boss Instruments, Ltd. · Class I
BOSS Instruments — Boss Instruments, Ltd. · 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

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Manufacturer

Manufacturer: Boss Instruments, Ltd.

Sources (1)

FDA UDI 4ed23916-d02b-435c-bcb5-13882c8a442e 35 fields · synced Jun 9, 2026