VariTrax Instrument Kit

FDA UDI

Class I (US FDA UDI)

by Circumfix Solutions, Inc

Identity

Trade Name: VariTrax Instrument Kit FDA UDI
Generic Name: General-purpose surgical scissors, single-use FDA UDI
Device Name: VariTrax Instrument Kit FDA UDI
Model / Reference: CFIK-INST FDA UDI
Description: VariTrax Instrument Kit FDA UDI

Identifiers

Primary DI / UDI-DI: 00850049938082 FDA UDI
FDA Product Code: HTZ FDA UDI
GMDN Term: General-purpose surgical scissors, 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

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

Sterilization Method

Dry Heat Sterilization FDA UDI

MRI Safety

MR Safe FDA UDI

Category: General-purpose surgical scissors, single-use

VariTrax Instrument Kit by Circumfix Solutions, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose surgical scissors, single-use.

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Surgical Direct — SURGICAL DIRECT, INC. · Class I
Sklar — Sklar Corporation · Class I
Centurion — Centurion Medical Products · Class I
Sklar® — Sklar Corporation · Class I
Bioseal Inc. — BIOSEAL · Class I
Surgical Direct — SURGICAL DIRECT, INC. · Class I
Sklar — Sklar Corporation · 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: Circumfix Solutions, Inc

Sources (1)

FDA UDI 7b331734-edad-4b4e-895a-17d4b2b9e8be 33 fields · synced Jun 8, 2026