FDA.reportPublic FDA data

CENTURION

Primary DI
10653160330516
Brand
CENTURION
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
MNS12160
Catalog number
MNS12160
Device description
GYN PROCEDURE TRAY
Published
2019-10-04
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
00653160330519PackageGS112In Commercial Distribution
10653160330516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160330519006531603305196531603305190653160330519
1065316033051610653160330516

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
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
10809160529447HalyardAVID MEDICAL, INC.LRO2026-08-08
10809160529188HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529195HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529201HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529225HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529232HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529249HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529256HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529263HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529270HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529287HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529294HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529300HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529317HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529324HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529348HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529355HalyardAVID MEDICAL, INC.LRO2026-08-07
10885632529412SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-07
10885632529429SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-07
10885632529436SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-07
10809160528365HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528372HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528389HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528419HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528433HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528440HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528457HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528488HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528495HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528501HalyardAVID MEDICAL, INC.LRO2026-08-03