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
10653160394068CENTURIONSUT11035ASUT11035A2026-07-21
10653160239369CENTURIONCHT805CHT8052022-01-01
10653160243694CENTURIONSUT17770SUT177702022-01-02
10653160277859CENTURIONSUT19145SUT191452022-01-02
10653160283966CENTURIONCVI4145CVI41452017-08-14
10653160285267CENTURIONMNS9625MNS96252022-01-02
10653160317937CENTURIONTRI66800TRI668002022-01-02
10653160322948CENTURIONSUT20915SUT209152022-01-02
10653160330783CENTURIONSUT21230ASUT21230A2022-01-02
10653160333883CENTURIONSUT18765ASUT18765A2022-01-02
10653160345220CENTURIONMNS13075MNS130752022-01-01
10653160360247CENTURIONMNS7285AMNS7285A2023-05-22
10653160374183CENTURIONMNS11780BMNS11780B2024-05-02
00653160013641CENTURIONMNS1080MNS10802022-01-01
00653160017762CENTURIONUVT235UVT2352022-01-02
00653160191349CENTURIONMNS5555MNS55552022-01-01
00653160199352CENTURIONSUT1243ASUT1243A2022-01-02
00653160200867CENTURIONSUT15260SUT152602022-01-02
00653160228397CENTURIONSUT17155SUT171552022-01-02
00653160130683Centurion589784ST589784ST2022-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS17798A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS179150Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS190180Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS190730Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS190920Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS190930Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS194550Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS195260Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS13932C0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-25
B098AMS16019B0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-25
B098AMS17843A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-25
B098AMS18256A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-25
B098AMS187260Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-25
B098AMS5861D0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-25
10809160527825HalyardAVID MEDICAL, INC.LRO2026-07-24
10809160527788HalyardAVID MEDICAL, INC.LRO2026-07-23
10809160527801HalyardAVID MEDICAL, INC.LRO2026-07-23
10809160527818HalyardAVID MEDICAL, INC.LRO2026-07-23
10809160527726HalyardAVID MEDICAL, INC.LRO2026-07-22
10809160527733HalyardAVID MEDICAL, INC.LRO2026-07-22
10809160527740HalyardAVID MEDICAL, INC.LRO2026-07-22
B098AMS15343A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-22
B098AMS174900Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-22
B098AMS187270Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-22
10653160394068CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONLRO2026-07-21
10653160394105MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394150MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394167MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394174MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394266MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21