FDA.reportPublic FDA data

CENTURION

Primary DI
10653160394242
Brand
CENTURION
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
CIT7621
Catalog number
CIT7621
Device description
YALE CIRC TRAY
Published
2026-10-05
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
00653160394245PackageGS116In Commercial Distribution
10653160394242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160394245006531603942456531603942450653160394245
1065316039424210653160394242

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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
10653160393450CENTURIONCVI5404CVI54042026-10-05
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
10653160341222CENTURIONCMPSN001ACMPSN001A2020-01-27
00653160005301CENTURION75121751212022-01-01
00653160081756CENTURION66965669652021-12-31
10653160251729CENTURIONMNS7810MNS78102022-01-01
10653160254799CENTURIONCHT890CHT8902022-01-01
10653160257028CENTURIONSUT18270SUT182702022-01-02
10653160257417CENTURIONCIT5460CIT54602016-09-05
10653160279068CENTURIONSUT19360SUT193602022-01-02
10653160291060CENTURIONMNS9970MNS99702022-01-02
10653160292029CENTURIONMNS9715MNS97152022-01-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815849020917Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
00815849022768Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
00815849022775Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
00815849022782Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
00815849022836Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
00815849025288Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
00815849025493Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
00815849025844Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
10198956371019CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956474987CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956504172CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956518629CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956520080CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956534520CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956535237CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956538375CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956539761CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956547322CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956549982CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956554016CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956555570CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956561281CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956565838CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956569959CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956570849CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956575035CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956575288CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956582842CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956583061CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956586482CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06