FDA.report

AVID TruCustom

Primary DI
20809160151850
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
ROSW042-11_0004
Catalog number
ROSW042-11
Published
2017-07-07
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

Related Records

Contact Domains

Product Codes

CodeName
OJHOrthopedic tray

Product Code Classifications

CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20809160151850PackageGS12In Commercial Distribution
10809160151853PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080916015185020809160151850
1080916015185310809160151853

GMDN Terms

TermDefinition
Orthopaedic surgical procedure kit, medicatedA collection of various sterile orthopaedic surgical instruments, dressings, and the necessary materials, which includes a pharmaceutical(s) intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. This is a single-use device.

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
+1(888) 564-7153PIQ@owens-minor.com

Regulatory Flags

DUNS number
015623119
Device count
1
DM exempt
true
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
true

Other Devices From This Company

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20809160517243HalyardAVMD050-01_0007AVMD050-012026-03-24
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20809160517090HalyardLIFE0240_0006LIFE02402026-03-23
20809160517120HalyardKAFB027_0010KAFB0272026-03-23
20809160517137HalyardUFCF010-03_0008UFCF010-032026-03-23
20809160517144HalyardVMCD018-11_0004VMCD018-112026-03-23
20809160517151HalyardVAML019-09_0004VAML019-092026-03-23
20809160517168HalyardNHJV7000-20_0008NHJV7000-202026-03-23
20809160517175HalyardEAMC109-06_0008EAMC109-062026-03-23
20809160517182HalyardOSTK19-01_0007OSTK19-012026-03-23
20809160517199HalyardDUAC16-01_0010DUAC16-012026-03-23
20809160517205HalyardVAML058_0017VAML0582026-03-23
20809160517212HalyardSAMT100-12_0007SAMT100-122026-03-23
20809160517229HalyardESED52-01_0013ESED52-012026-03-23
20809160516734HalyardLIFE0156-03_0008LIFE0156-032026-03-20
20809160516741HalyardWERP43-01_0002WERP43-012026-03-20
20809160516758HalyardWEGL20-01_0004WEGL20-012026-03-20
20809160516765HalyardWEHY18-01_0002WEHY18-012026-03-20
20809160516772HalyardWEGB22-01_0002WEGB22-012026-03-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00191072241979ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00191072241986ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00191072241993ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00191072242006ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00191072242013ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00191072242020ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00869397000013XL Instrument SetSi-Bone Inc.OJH2026-03-24
00869397000020Radiolucent Instrument SetSi-Bone Inc.OJH2026-03-24
00869397000037Standard Instrument SetSi-Bone Inc.OJH2026-03-24
00869397000044Removal System Instrument SetSi-Bone Inc.OJH2026-03-24
008693970000517.5mm & 10.75mm Instrument SetSi-Bone Inc.OJH2026-03-24
50198956278484CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956302929CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956307986CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956308006CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956357981CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956360530CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956362015CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
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50198956415186CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956425697CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956426397CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956426762CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956427394CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956429312CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24