Isi

FDA UDI

Class I (US FDA UDI)

by Instrument Specialists, Inc.

Identity

Trade Name: ISI FDA UDI
Generic Name: Upper-limb traction wrap/trap, reusable FDA UDI
Device Name: Sizing Kit Nylon Finger Traps - 1 each on ring FDA UDI
Model / Reference: Nylon Finger Traps FDA UDI
Description: Sizing Kit Nylon Finger Traps - 1 each on ring FDA UDI

Identifiers

Catalog Number: K-950 FDA UDI
Primary DI / UDI-DI: 00810045921518 FDA UDI
FDA Product Code: ILZ FDA UDI
GMDN Term: Upper-limb traction wrap/trap, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.5925 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Upper-limb traction wrap/trap, reusable

Isi by Instrument Specialists, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Upper-limb traction wrap/trap, reusable.

Ambler Surgical — Ambler Surgical, LLC · Class II
TRAPS, FINGER, DOUBLE, 5/PK — AliMed, LLC · Class I
INFLATABLE CUFF/STRAP ASSEMBLY — Mizuho Orthopedic Systems, Inc. · Class I
Novo Surgical — NOVO SURGICAL, INC. · Class I
Ambler Surgical — Ambler Surgical, LLC · Class II
TRAPS, FINGER, SINGLES, 5/PK — AliMed, LLC · Class I
FINGER TRAP SET (5), ADULT, LITEGRIP — Mizuho Orthopedic Systems, Inc. · Class I
Ambler Surgical — Ambler Surgical, LLC · 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: Instrument Specialists, Inc.

Sources (1)

FDA UDI 73b501d2-ad51-40cf-ad3f-d68c0c31ad34 34 fields · synced Jun 6, 2026