Reprocessed CTR Indiana Tome Blade

FDA UDI

Class I (US FDA UDI)

by Suretek Medical

Identity

Trade Name: Reprocessed CTR Indiana Tome Blade FDA UDI
Generic Name: Hand ligament surgical release instrument FDA UDI
Model / Reference: 200060 FDA UDI

Identifiers

Primary DI / UDI-DI: B3902000601 FDA UDI
FDA Product Code: FZX FDA UDI
GMDN Term: Hand ligament surgical release instrument 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

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Hand ligament surgical release instrument

Reprocessed CTR Indiana Tome Blade by Suretek Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Arthrex — Provision · 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: Suretek Medical

Sources (1)

FDA UDI 6825d33d-1a20-43ec-9324-e88a8f7565c4 32 fields · synced Jun 7, 2026