FDA.reportPublic FDA data

Centurion

Primary DI
00653160352580
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
SUT15640
Catalog number
SUT15640
Device description
AULTMAN LACERATION TRAY
Published
2022-05-04
Public version status
New
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
LRPTRAY, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2
LRPTray, SurgicalGeneral, Plastic Surgery1

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
00653160352580PackageGS112In Commercial Distribution
10653160352587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160352580006531603525806531603525800653160352580
1065316035258710653160352587

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA general-purpose collection of various surgical instruments, dressings, and materials, including a pharmaceutical component, intended to be used to assist a range of surgical procedures across multiple clinical specialities. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463CUSTOMERSERVICE@MEDLINE.COM

Regulatory Flags#

DUNS number
017246562
Device count
1
DM exempt
true
Premarket exempt
true
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
10653160393757CENTURIONCIT5215ACIT5215A2026-05-27
10653160241010CenturionHGL30HGL302022-01-01
10653160246305CenturionIVS1515IVS15152022-01-01
10653160246589CenturionSV733UDTSV733UDT2022-01-02
10653160250005CenturionHG440XTHG440XT2022-01-01
10653160250234CenturionFCS300FCS3002022-01-01
10653160258063CenturionIV690IV6902022-01-01
10653160262756CenturionANCPR320STANCPR320ST2022-01-01
10653160267270CenturionSV430AFXTSV430AFXT2022-01-02
10653160267294CenturionSV733AFXTSV733AFXT2022-01-02
10653160270164CenturionANC32XT-6ANC32XT-62022-01-01
10653160270171CenturionANC52XT-6ANC52XT-62022-01-01
10653160270201CenturionSCVP44XT-6SCVP44XT-62022-01-02
10653160270218CenturionSCVP66XT-6SCVP66XT-62022-01-02
10653160270256CenturionSV44UXT2-6SV44UXT2-62022-01-02
10653160270263CenturionSV60NXT-6SV60NXT-62022-01-02
10653160270348CenturionSV46VST-6SV46VST-62022-01-02
10653160270386CenturionSV48NFST-6SV48NFST-62022-01-02
10653160270393CenturionSV48VXT-6SV48VXT-62022-01-02
10653160270409CenturionSV80FST-6SV80FST-62022-01-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956261952CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956331235CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956380615CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-06
10198956393424CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956427198CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956445864CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956456969CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956473072CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956477209CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956477384CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-06
10198956487161CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956493773CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956494619CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956497443CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956497887CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-06
10198956498440CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956498747CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956499553CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956502765CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956504059CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956504127CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956504820CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956508897CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956509221CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956510081CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956515505CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956524576CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956525122CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956525351CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956525719CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06