FDA.reportPublic FDA data

CENTURION

Primary DI
00653160228786
Brand
CENTURION
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
PE2900
Catalog number
PE2900
Device description
VAGINAL BLEED TRAY
Published
2016-11-11
Public version status
Update
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
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
10653160228783PackageGS124In Commercial Distribution
00653160228786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1065316022878310653160228783
00653160228786006531602287866531602287860653160228786

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)633-5463service@medline.com

Regulatory Flags#

DUNS number
017246562
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
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