Tigon Medical

FDA UDI

Class I (US FDA UDI)

by Tigon Medical Llc

Identity

Trade Name: Tigon Medical FDA UDI
Generic Name: Suturing needle, single-use FDA UDI
Device Name: Needle for Passer (disposable) FDA UDI
Model / Reference: TIGO-12 FDA UDI
Description: Needle for Passer (disposable) FDA UDI

Identifiers

Catalog Number: TIGO-12 FDA UDI
Primary DI / UDI-DI: 00854288008216 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Suturing needle, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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

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: Suturing needle, single-use

Tigon Medical by Tigon Medical 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: Tigon Medical Llc

Sources (1)

FDA UDI e33bfba5-f57f-4eca-829b-4aef0d8b5a2b 35 fields · synced May 30, 2026