Tsi

FDA UDI

Class I (US FDA UDI)

by Tedan Surgical Innovations, L.l.c.

Identity

Trade Name: TSI FDA UDI
Generic Name: Soft-tissue surgical hook, single-use FDA UDI
Device Name: BLUNT SCALP HOOK, MEDIUM FDA UDI
Model / Reference: TK-0404 FDA UDI
Description: BLUNT SCALP HOOK, MEDIUM FDA UDI

Identifiers

Primary DI / UDI-DI: 00843059100037 FDA UDI
FDA Product Code: GDG FDA UDI
GMDN Term: Soft-tissue surgical hook, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

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

Category: Soft-tissue surgical hook, single-use

Tsi by Tedan Surgical Innovations, L.l.c. — 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: Tedan Surgical Innovations, L.l.c.

Sources (1)

FDA UDI 05e34538-6719-41d1-a108-f308236fdbea 33 fields · synced Jun 1, 2026