Centurion

FDA UDI

Class II (US FDA UDI)

by Centurion Medical Products

Identity

Trade Name: Centurion FDA UDI
Generic Name: Surgical/examination garment kit FDA UDI
Device Name: PUNCH BIOPSY KIT FDA UDI
Model / Reference: MNS8245 FDA UDI
Description: PUNCH BIOPSY KIT FDA UDI

Identifiers

Catalog Number: MNS8245 FDA UDI
Primary DI / UDI-DI: 10653160372288 FDA UDI
510(k) Number: K213481 FDA UDI
FDA Product Code: LRO FDA UDI
GMDN Term: Surgical/examination garment kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4370 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Surgical/examination garment kit

Centurion by Centurion Medical Products — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Safehand — Winsight International Solutions, Inc. · Class II

Cleared under the same submission

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 II	Pending data

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Manufacturer

Manufacturer: Centurion Medical Products

Sources (1)

FDA UDI 2ad64899-b130-47a0-84a2-68ad856ffdde 36 fields · synced Jun 8, 2026