FDA.reportPublic FDA data

AVID TruCustom

Primary DI
10809160014073
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
LIFG002_0007
Catalog number
LIFG002
Published
2016-09-10
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160014070PackageGS110In Commercial Distribution
10809160014073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916001407020809160014070
1080916001407310809160014073

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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(888) 564-7153AVIDComplaints@Owens-Minor.com

Regulatory Flags#

DUNS number
015623119
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160526989HalyardLIFE0223-02_0005LIFE0223-022026-07-10
10809160526996HalyardBMHT110-04_0001BMHT110-042026-07-10
10809160526903HalyardBTMF007-06_0001BTMF007-062026-07-09
10809160526910HalyardDGBB41-02_0004DGBB41-022026-07-09
10809160526927HalyardBMHT200-03_0004BMHT200-032026-07-09
10809160526934HalyardSGCB56-03_0006SGCB56-032026-07-09
10809160526941HalyardSFSSHND415-02_0001SFSSHND415-022026-07-09
10809160526958HalyardLAKC010-08_0004LAKC010-082026-07-09
10809160526965HalyardSFSAKAH37-04_0001SFSAKAH37-042026-07-09
10809160526842HalyardAKCS54-03_0001AKCS54-032026-07-08
10809160526859HalyardDUAG11-01_0007DUAG11-012026-07-08
10809160526880HalyardSELF108-04_0005SELF108-042026-07-08
10809160526897HalyardHVSP206-05_0007HVSP206-052026-07-08
10809160526804HalyardSBHP01-02_0008SBHP01-022026-07-07
10809160526811HalyardAVMD027-02_0002AVMD027-022026-07-07
10809160526828HalyardSGGR61-04_0003SGGR61-042026-07-07
10809160526835HalyardSGCY35-02_0007SGCY35-022026-07-07
10809160526156HALYARDPVHM204-02PVHM204-022026-07-06
10809160526484HalyardLANC009-34_0008LANC009-342026-07-06
10809160526491HalyardSGMN13-04_0011SGMN13-042026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS14885C0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-12
B098AMS17983A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-12
B098AMS18306A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-12
B098AMS192890Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-12
B098AMS192920Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-12
B098AMS8144C0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-12
10809160526989HalyardAVID MEDICAL, INC.LRO2026-07-10
10809160526996HalyardAVID MEDICAL, INC.LRO2026-07-10
10885632524950SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-07-10
10885632526978SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-07-10
10885632526992SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-07-10
10198956074668CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956119260CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956286719CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956386303CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956387959CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956420076CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956425996CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956457119CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956459878CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956462007CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956462151CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956473478CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956475427CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956483675CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956485068CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956490956CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956491496CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956491533CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956491908CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09