FDA.reportPublic FDA data

CENTURION

Primary DI
10653160318170
Brand
CENTURION
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
OR2050
Catalog number
OR2050
Device description
DG PACK SURG SET UP DECATUR
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653160318173PackageGS112In Commercial Distribution
10653160318170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160318173006531603181736531603181730653160318173
1065316031817010653160318170

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, 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
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
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
10653160313243CENTURIONSUT20670SUT206702022-01-02
10653160313823CENTURIONSUT20685SUT206852022-01-02
10653160316626CENTURIONMNS11230MNS112302018-05-03
10653160317210CENTURIONTC7955TC79552022-01-02
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
10809160530702HalyardAVID MEDICAL, INC.LRO2026-08-19
10809160530719HalyardAVID MEDICAL, INC.LRO2026-08-19
10809160530726HalyardAVID MEDICAL, INC.LRO2026-08-19
10809160530740HalyardAVID MEDICAL, INC.LRO2026-08-19
10809160530771HalyardAVID MEDICAL, INC.LRO2026-08-19
10809160530788HalyardAVID MEDICAL, INC.LRO2026-08-19
10809160530818HalyardAVID MEDICAL, INC.LRO2026-08-19
10809160530825HalyardAVID MEDICAL, INC.LRO2026-08-19
10809160530894HalyardAVID MEDICAL, INC.LRO2026-08-19
10809160530900HalyardAVID MEDICAL, INC.LRO2026-08-19
10885632530845SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-19
10885632530852SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-19
10885632530869SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-19
10885632530876SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-19
10885632530883SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-19
10885632530913SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-19
B098AMS197320Aligned Medical SolutionsAligned Medical SolutionsLRO2026-08-19
10198956361003CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-18
10198956510678CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-18
10198956516915CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-18
10198956542273CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-18
10198956549609CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-18
10198956555303CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-18
10809160530276HalyardAVID MEDICAL, INC.LRO2026-08-18
10809160530283HalyardAVID MEDICAL, INC.LRO2026-08-18
10809160530306HalyardAVID MEDICAL, INC.LRO2026-08-18
10809160530313HalyardAVID MEDICAL, INC.LRO2026-08-18
10809160530320HalyardAVID MEDICAL, INC.LRO2026-08-18
10809160530344HalyardAVID MEDICAL, INC.LRO2026-08-18
10809160530351HalyardAVID MEDICAL, INC.LRO2026-08-18