FDA.reportPublic FDA data

Centurion

Primary DI
10653160161448
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
A9TST
Catalog number
A9TST
Device description
STERILE PEN
Published
2022-01-01
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10653160161448PackageGS1150In Commercial Distribution
00653160161441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1065316016144810653160161448
00653160161441006531601614416531601614410653160161441

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00653160294248CenturionMNS101552016-11-11
00653160315974CenturionCIT66352018-04-09
00653160284218CenturionCIT59202017-03-03
00653160274882CenturionPE31802018-02-11
00653160389753CenturionDM485BDM485B2025-09-17
00653160389296CenturionBT235BBT235B2025-08-24
00653160389319CenturionCSS640ACSS640A2025-08-24
00653160389494CenturionDT23104DT231042025-08-24
00653160388992CenturionSUT14785ASUT14785A2025-08-18
00653160389357CenturionDT23103DT231032025-08-18
00653160389067CenturionDYNDV2722DYNDV27222025-08-09
00653160389074CenturionSUT19525ASUT19525A2025-08-09
00653160389159CenturionIVS1090BIVS1090B2025-08-09
00653160388978CenturionMNS10875BMNS10875B2025-08-02
00653160386936CenturionIVS4222IVS42222025-07-21
00653160388909CenturionSUT21465BSUT21465B2025-07-21
00653160388848CenturionDYNDC3166DDYNDC3166D2025-07-18
00653160388732CenturionSUT19955BSUT19955B2025-07-14
00653160388770CenturionDM875ADM875A2025-07-14
00653160388794CenturionSUT12485ASUT12485A2025-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800171Adler Instrument CompanyAdler, Inc.MDM2026-05-26
00810220800188Adler Instrument CompanyAdler, Inc.MDM2026-05-26
06438394002678Activa InstrumentBioretec OyMDM2026-03-23
06438394002685Activa InstrumentBioretec OyMDM2026-03-23
06438394002692Activa InstrumentBioretec OyMDM2026-03-23
06438394020382Activa InstrumentBioretec OyMDM2026-03-23
06438394010956Activa InstrumentBioretec OyMDM2026-03-23
00198506089619ELMED INCORPORATEDELMED INCORPORATEDMDM2026-03-17
00888867519459Arthrex®ARTHREX, INC.MDM2026-03-16
00888867519473Arthrex®ARTHREX, INC.MDM2026-03-16
00888867519503Arthrex®ARTHREX, INC.MDM2026-03-16
00888867519510Arthrex®ARTHREX, INC.MDM2026-03-16
00888867529755Arthrex®ARTHREX, INC.MDM2026-03-16
00888867529793Arthrex®ARTHREX, INC.MDM2026-03-16
00888867529823Arthrex®ARTHREX, INC.MDM2026-03-16
00198506089510ELMED INCORPORATEDELMED INCORPORATEDMDM2026-03-13
00810158219236PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219243PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219250PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219281PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219304PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219311PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219359PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219373PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219007PRINCETONPrinceton Medical Group, Inc.MDM2026-03-11
00810158219014PRINCETONPrinceton Medical Group, Inc.MDM2026-03-11
00810158219021PRINCETONPrinceton Medical Group, Inc.MDM2026-03-11
00810158219038PRINCETONPrinceton Medical Group, Inc.MDM2026-03-11
00810158219069PRINCETONPrinceton Medical Group, Inc.MDM2026-03-11
00810158219090PRINCETONPrinceton Medical Group, Inc.MDM2026-03-11