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Biotronix Healthcare

FDA UDI

Class I (US FDA UDI)

by Biotronix Healthcare Industries Inc.

Identity

Trade Name
Biotronix Healthcare FDA UDI
Generic Name
General surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
Minor Laceration Tray w/ Instrument FDA UDI
Model / Reference
OR4004 FDA UDI
Description
Minor Laceration Tray w/ Instrument FDA UDI

Identifiers

Catalog Number
OR4004 FDA UDI
Primary DI / UDI-DI
00850005165057 FDA UDI
FDA Product Code
KDD FDA UDI
GMDN Term
General surgical procedure kit, non-medicated, 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: General surgical procedure kit, non-medicated, single-use

Biotronix Healthcare by Biotronix Healthcare Industries Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biotronix Healthcare Industries Inc.

Sources (1)

  • FDA UDI 21a1849c-7d42-44f5-8bcb-90592bfa6bea 36 fields · synced Jun 1, 2026