FDA.reportPublic FDA data

Centurion

Primary DI
00653160226959
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
TC7710
Catalog number
TC7710
Device description
TRACHEOTOMY 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
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
10653160226956PackageGS110In Commercial Distribution
00653160226959PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1065316022695610653160226956
00653160226959006531602269596531602269590653160226959

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy kit, single-useA collection of sterile surgical instruments, dressings/swabs, syringe, dilators, tracheostomy tubes and other items intended to be used to create a percutaneous opening in the trachea (tracheotomy) for the insertion of a tracheostomy tube to relieve upper airway obstruction and to facilitate ventilation. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(517)546-5400CUSTOMERSERVICE@CENTURIONMP.COM

Regulatory Flags#

DUNS number
017246562
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
10653160318170CENTURIONOR2050OR20502022-01-02
10653160318361CENTURIONMNS11280MNS112802022-01-01
10653160319160CENTURIONIV8675IV86752018-07-16
10653160323211CENTURIONMNS11745MNS117452022-01-01
10653160324065CENTURIONMNS11760MNS117602022-01-01
10653160325000CENTURIONCIT6905CIT69052022-01-01

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