FDA.report

Centurion

Primary DI
10653160128533
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
SP1225
Catalog number
SP1225
Device description
SCRUB SPONGE
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
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NABGauze / sponge,nonresorbable for external use

Product Code Classifications

CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10653160128533PackageGS150In Commercial Distribution
00653160128536PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1065316012853310653160128533
00653160128536006531601285366531601285360653160128536

GMDN Terms

TermDefinition
Surgical scrub spongeA hand-held device that includes an absorbent, porous material designed to wash the skin of the arms, hands, and the fingernails in preparation for a medical/surgical procedure. It is typically multilayered and impregnated with an antimicrobial solution. 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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