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Centurion

FDA UDI

Class II (US FDA UDI)

by Centurion Medical Products

Identity

Trade Name
Centurion FDA UDI
Generic Name
Surgical penis clamp, single-use FDA UDI
Model / Reference
330CR FDA UDI

Identifiers

Primary DI / UDI-DI
00653160197495 FDA UDI
510(k) Number
K890897 FDA UDI
FDA Product Code
HFX FDA UDI
GMDN Term
Surgical penis clamp, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.4530 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Surgical penis clamp, single-use

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

Similar devices

Also classified as Surgical penis clamp, single-use.

Cleared under the same submission

K890897 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Centurion Medical Products

Sources (1)

  • FDA UDI db8d9520-d36c-4493-a7cb-781e49338d8d 34 fields · synced Jun 6, 2026