FDA.reportPublic FDA data

CENTURION

Primary DI
10653160395232
Brand
CENTURION
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
CIT6750A
Catalog number
CIT6750A
Device description
CIRCUMCISION TRAY
Published
2026-10-13
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

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
00653160395235PackageGS124In Commercial Distribution
10653160395232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160395235006531603952356531603952350653160395235
1065316039523210653160395232

GMDN Terms#

Term, Definition table
TermDefinition
Circumcision kit, single-useA collection of sterile devices designed to perform a circumcision procedure. It typically includes a disinfectant, circumcision clamp, scissors, and a scalpel. 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
true
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
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
10653160394754CENTURIONCIT5165ACIT5165A2026-10-05
10653160394785CENTURIONCIT5350ACIT5350A2026-10-05
10653160394808CENTURIONCIT4660ACIT4660A2026-10-05
10653160328131CENTURIONDT22125DT221252022-01-01
10653160353461CENTURIONDT21830BDT21830B2022-05-31
10653160381341CENTURIONDM1336DM13362024-10-07
10653160323082CENTURIONCHT1730CHT17302022-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956562950CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-13
10198956593770CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-13
10198956597891CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-13
10198956599086CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-13
10198956599345CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-13
10198956604322CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-13
10809160540565HalyardAVID MEDICAL, INC.LRO2026-10-13
10809160540572HalyardAVID MEDICAL, INC.LRO2026-10-13
10809160540589HalyardAVID MEDICAL, INC.LRO2026-10-13
10809160540602HalyardAVID MEDICAL, INC.LRO2026-10-13
10885632540615SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-10-13
10198956331259CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956352230CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956399051CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956507425CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956508057CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956519701CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956523142CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956537491CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956540620CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956542716CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956546110CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956551015CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956553699CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956554689CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956555709CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956558335CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956566699CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956568143CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956568181CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12