FDA.reportPublic FDA data

Centurion

Primary DI
10653160344353
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
ULT2175C
Catalog number
ULT2175C
Device description
ULTIMATE LINE TRAY
Published
2022-01-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212258000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212258000Medline Cardiovascular Procedure KitMedline Industries, Inc.2021-12-03LRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653160344356PackageGS110In Commercial Distribution
10653160344353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160344356006531603443566531603443560653160344356
1065316034435310653160344353

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(517)546-5400CUSTOMERSERVICE@CENTURIONMP.COM

Regulatory Flags#

DUNS number
017246562
Device count
1
DM exempt
true
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160251729CENTURIONMNS7810MNS78102022-01-01
10653160254799CENTURIONCHT890CHT8902022-01-01
10653160257028CENTURIONSUT18270SUT182702022-01-02
10653160257417CENTURIONCIT5460CIT54602016-09-05
10653160279068CENTURIONSUT19360SUT193602022-01-02
10653160291060CENTURIONMNS9970MNS99702022-01-02
10653160292029CENTURIONMNS9715MNS97152022-01-02
10653160292562CENTURIONMNS9820MNS98202022-01-02
10653160293798CENTURIONIV8310EIV8310E2017-08-18
10653160310006CENTURIONID2060ID20602021-11-29
10653160313243CENTURIONSUT20670SUT206702022-01-02
10653160313823CENTURIONSUT20685SUT206852022-01-02
10653160316626CENTURIONMNS11230MNS112302018-05-03
10653160317210CENTURIONTC7955TC79552022-01-02
10653160318170CENTURIONOR2050OR20502022-01-02
10653160318361CENTURIONMNS11280MNS112802022-01-01
10653160319160CENTURIONIV8675IV86752018-07-16
10653160323211CENTURIONMNS11745MNS117452022-01-01
10653160324065CENTURIONMNS11760MNS117602022-01-01
10653160325000CENTURIONCIT6905CIT69052022-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160532966HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160532973HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160532980HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160532997HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160533000HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160533017HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160533024HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160533031HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160533048HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160533055HalyardAVID MEDICAL, INC.LRO2026-09-05
10198956333420CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956395947CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956462977CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956486058CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956530744CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956531611CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956535985CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956541177CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956541702CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956542532CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956546509CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956546585CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956547285CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956548022CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956551763CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956552364CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956552401CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956553385CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956554399CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956554429CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04