FDA.reportPublic FDA data

AVID TruCustom

Primary DI
10809160047439
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
SAMM032-07_0004
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

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
20809160047436PackageGS16In Commercial Distribution
10809160047439PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916004743620809160047436
1080916004743910809160047439

GMDN Terms#

Term, Definition table
TermDefinition
TonsillectomeA hand-held manual surgical instrument designed to remove tonsils during a toncillectomy. It can be designed as either a flexible loop for grasping and holding the tonsil or a metal frame which holds and guides a sliding knife blade (a guillotine). The loop type holds the tonsil so it may be surgically cut with a knife. The frame type has a variety of designs of manual cranks that operate the sliding knife blade which cuts off the tonsil. This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

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
10809160528365HalyardPSJH0015-02_0014PSJH0015-022026-08-03
10809160528372HalyardSFSAKOR36-02_0001SFSAKOR36-022026-08-03
10809160528389HalyardAKOR36-03_0002AKOR36-032026-08-03
10809160528396HalyardAKCR19-03_0003AKCR19-032026-08-03
10809160528402HalyardBMHT500-03_0005BMHT500-032026-08-03
10809160528419HalyardBMHU006-07_0007BMHU006-072026-08-03
10809160528426HalyardSELF137-05_0005SELF137-052026-08-03
10809160528433HalyardLANC039-31_0002LANC039-312026-08-03
10809160528440HalyardBMHT202-05_0004BMHT202-052026-08-03
10809160528457HalyardBMHT401-04_0006BMHT401-042026-08-03
10809160528464HalyardESCC82-02_0010ESCC82-022026-08-03
10809160528471HalyardLANC015-35_0011LANC015-352026-08-03
10809160528488HalyardBMHT400-03_0013BMHT400-032026-08-03
10809160528495HalyardBAMW001-03_0002BAMW001-032026-08-03
10809160528501HalyardQPTH29-02_0007QPTH29-022026-08-03
10809160528518HalyardSFSBMHU006-07_0001SFSBMHU006-072026-08-03
10809160528525HalyardHVBM219-04_0005HVBM219-042026-08-03
10809160528532HalyardSFSBAMW001-03_0001SFSBAMW001-032026-08-03
10809160528549HalyardMEEN42-03_0007MEEN42-032026-08-03
10809160528556HalyardDAMH300-03_0005DAMH300-032026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160528365HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528372HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528389HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528419HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528433HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528440HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528457HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528488HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528495HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528501HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528518HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528525HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528532HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528549HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528556HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528570HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528594HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528617HalyardAVID MEDICAL, INC.LRO2026-08-03
10885632528620SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-03
B098AMS16817B0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-08-03
B098AMS17579A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-08-03
B098AMS178930Aligned Medical SolutionsAligned Medical SolutionsLRO2026-08-03
B098AMS178970Aligned Medical SolutionsAligned Medical SolutionsLRO2026-08-03
B098AMS191170Aligned Medical SolutionsAligned Medical SolutionsLRO2026-08-03
10809160528341HALYARDAVID MEDICAL, INC.LRO2026-08-01
10198956352315CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-31
10198956364998CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-31
10198956395503CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-31
10198956453180CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-31
10198956485358CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-31