FDA.reportPublic FDA data

CENTURION

Primary DI
10653160313243
Brand
CENTURION
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
SUT20670
Catalog number
SUT20670
Device description
SUTURE TRAY
Published
2022-01-02
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
00653160313246PackageGS120In Commercial Distribution
10653160313243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160313246006531603132466531603132460653160313246
1065316031324310653160313243

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
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
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
10653160328308CENTURIONSUT21110SUT211102022-01-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160531860HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531877HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531914HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531921HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531945HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531952HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531976HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531983HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531990HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160532010HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160532034HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160532041HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160532058HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160532089HalyardAVID MEDICAL, INC.LRO2026-08-27
10198956437746CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956504462CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956509078CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956511163CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956523814CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956524446CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956531703CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956534896CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956534971CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956535107CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956535473CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956537576CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956544499CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956547636CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956548404CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956549937CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26