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
10653160286844CENTURIONI67350I673502022-01-01
10653160349006CENTURION67850678502021-11-29
00653160022360CENTURION66360663602021-12-31
10653160395225CENTURIONIVS4231IVS42312026-10-14
10653160395256CENTURIONIVS3945BIVS3945B2026-10-14
10653160395355CENTURIONCIT3065BCIT3065B2026-10-14
10653160395232CENTURIONCIT6750ACIT6750A2026-10-13
10653160393443CENTURIONDT23110DT231102026-10-08
10653160394075CENTURIONDT21660CDT21660C2026-10-08
10653160393344CENTURIONDM1348DM13482026-10-07
10653160393818CENTURIONDT15200CDT15200C2026-10-07
10653160394464CENTURIONDT12565ADT12565A2026-10-07
10653160320265CENTURIONID1945AID1945A2022-01-01
10653160365815CENTURIONI69005I690052023-09-05
20653160251610CENTURIONFCS300XTFCS300XT2022-01-01
00653160013191CENTURIONHT855HT8552017-08-25
10653160393450CENTURIONCVI5404CVI54042026-10-05
10653160394242CENTURIONCIT7621CIT76212026-10-05
10653160394297CENTURIONCHT1885ACHT1885A2026-10-05
10653160394570CENTURIONCIT2285ACIT2285A2026-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160541111HalyardAVID MEDICAL, INC.LRO2026-10-22
10809160541128HalyardAVID MEDICAL, INC.LRO2026-10-22
10809160541166HalyardAVID MEDICAL, INC.LRO2026-10-22
10809160541173HalyardAVID MEDICAL, INC.LRO2026-10-22
10809160541203HalyardAVID MEDICAL, INC.LRO2026-10-22
10809160541227HalyardAVID MEDICAL, INC.LRO2026-10-22
10809160541234HalyardAVID MEDICAL, INC.LRO2026-10-22
10809160541258HalyardAVID MEDICAL, INC.LRO2026-10-22
10809160541289HalyardAVID MEDICAL, INC.LRO2026-10-22
10809160541319HalyardAVID MEDICAL, INC.LRO2026-10-22
10809160541326HalyardAVID MEDICAL, INC.LRO2026-10-22
10809160541333HalyardAVID MEDICAL, INC.LRO2026-10-22
10885632541131SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-10-22
10809160540992HalyardAVID MEDICAL, INC.LRO2026-10-21
10809160541012HALYARDAVID MEDICAL, INC.LRO2026-10-21
10809160541050Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.LRO2026-10-21
10809160541081HalyardAVID MEDICAL, INC.LRO2026-10-21
10809160541098HalyardAVID MEDICAL, INC.LRO2026-10-21
10809160541104HalyardAVID MEDICAL, INC.LRO2026-10-21
10809160540862HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540886HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540916HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540923HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540930HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540947HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540954HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540961HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540978HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540985HalyardAVID MEDICAL, INC.LRO2026-10-20
00748426262069Medline-MicrotekMicrotek Medical LLCLRO2026-10-19