FDA.reportPublic FDA data

Centurion

Primary DI
00653160154771
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
PE2665
Published
2016-11-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K213481000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213481000Medline General Surgery TrayMedline Industries, Inc.2022-05-24LRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10653160154778PackageGS120In Commercial Distribution
00653160154771PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1065316015477810653160154778
00653160154771006531601547716531601547710653160154771

GMDN Terms#

Term, Definition table
TermDefinition
Pelvic examination kitA collection of sterile devices designed to perform a pelvic examination. It contains all of the various instruments, specimen collection materials, and pharmaceuticals necessary for this procedure. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)248-4058CUSTOMERSERVICE@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
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
10198956377967CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956384774CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956499270CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956499980CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956519527CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956542457CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956544147CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956567627CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956568495CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956568501CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956569300CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956572607CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956581173CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956581234CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956583016CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956583702CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956583900CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956583979CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956583993CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19