Kirwan

FDA UDI

Class I (US FDA UDI)

by Kirwan Surgical Products Llc

Identity

Trade Name: Kirwan FDA UDI
Generic Name: Bone hook FDA UDI
Device Name: Bankart Shoulder Repair Instrument 7 1/2" (26.7cm) Ligature Carrier FDA UDI
Model / Reference: 50-1007 FDA UDI
Description: Bankart Shoulder Repair Instrument 7 1/2" (26.7cm) Ligature Carrier FDA UDI

Identifiers

Primary DI / UDI-DI: 00841019107881 FDA UDI
FDA Product Code: HAO FDA UDI
GMDN Term: Bone hook FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 882.4535 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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 7.5 Inch FDA UDI

Category: Bone hook

Kirwan by Kirwan Surgical Products Llc — 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: Kirwan Surgical Products Llc

Sources (1)

FDA UDI 7640a030-5f22-4cdd-95c0-a6d6417ab7ae 35 fields · synced Jun 1, 2026