FDA.report

Centurion

Primary DI
10653160359234
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
65240
Catalog number
65240
Device description
STERILE STRT KELLY HEMOSTAT (ZM-09417)
Published
2023-03-17
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
HRQHEMOSTAT

Product Code Classifications

CodeDeviceSpecialtyClass
HRQHemostatGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10653160359234PackageGS120In Commercial Distribution
20653160359231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1065316035923410653160359234
2065316035923120653160359231

GMDN Terms

TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, single-useA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues; it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. 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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