FDA.report

Centurion

Primary DI
10653160106111
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
SPS12STA
Catalog number
SPS12STA
Device description
STERILE TOOTHBRUSH
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
EFWTOOTHBRUSH, MANUAL

Product Code Classifications

CodeDeviceSpecialtyClass
EFWToothbrush, ManualDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10653160106111PackageGS1100In Commercial Distribution
00653160106114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1065316010611110653160106111
00653160106114006531601061146531601061140653160106114

GMDN Terms

TermDefinition
Oral care swabA device designed as a piece of non-treated, absorbent material on a wooden, paper, or plastic stick and intended to moisten and clean a patient's oral cavity to maintain normal mouth patency and hygiene. It is commonly used on intensive care and long-term care patients to administer moisture, mouthwash, or medications to improve the physical condition of the oral cavity and possibly help reduce the incidence of patient infection. It is typically applied to the patient by nursing staff in hospitals and institutions, or attendants in homecare settings. 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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