FDA.report

Centurion

Primary DI
00653160258462
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
ZC110ST
Catalog number
ZC110ST
Device description
ZIPSER PENIS CLAMP STERILE (ZC110)
Published
2022-01-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HXDCLAMP

Product Code Classifications

CodeDeviceSpecialtyClass
HXDClampGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00653160258462PackageGS120In Commercial Distribution
10653160258469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160258462006531602584626531602584620653160258462
1065316025846910653160258469

GMDN Terms

TermDefinition
Surgical penis clamp, single-useA sterile, hand-held manual surgical instrument designed to grasp the penis for manipulation during surgery (e.g., circumcision). It is typically a clip-like device e.g., with self-retaining levers. The penis is placed into this clamp that closes around or on the organ. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(517)546-5400CUSTOMERSERVICE@CENTURIONMP.COM

Regulatory Flags

DUNS number
017246562
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00653160388794CenturionSUT12485ASUT12485A2025-07-14

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