FDA.reportPublic FDA data

AVID TruCustom

Primary DI
10809160047446
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
WCCH001-02_0003
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
20809160047443PackageGS14In Commercial Distribution
10809160047446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916004744320809160047443
1080916004744610809160047446

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
Contains natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160532676HalyardMSBS14-05_0006MSBS14-052026-09-04
10809160532683HalyardMSTK53-06_0002MSTK53-062026-09-04
10809160532690HalyardMSCS51-06_0005MSCS51-062026-09-04
10809160532706HalyardSFSBPAR65-02_0003SFSBPAR65-022026-09-04
10809160532713HalyardBPAR65-02_0002BPAR65-022026-09-04
10809160532737HalyardFBCH103-07_0015FBCH103-072026-09-04
10809160532744HalyardMSTK53-07_0001MSTK53-072026-09-04
10809160532768HalyardBKAP27-03_0006BKAP27-032026-09-04
10809160532775HalyardEURO053-02_0003EURO053-022026-09-04
10809160532782HalyardKAFB008-10_0016KAFB008-102026-09-04
10809160532799HalyardWRNM019-16_0003WRNM019-162026-09-04
10809160532805HalyardNAMC436-13_0007NAMC436-132026-09-04
10809160532812HalyardNAMC433-07_0008NAMC433-072026-09-04
10809160532829HalyardWRNM025-12_0005WRNM025-122026-09-04
10809160532836HalyardEAMC1000-05AUX2_0002EAMC1000-05AUX22026-09-04
10809160532843HalyardWRNM007-18_0003WRNM007-182026-09-04
10809160532850HalyardNAMC474-06_0004NAMC474-062026-09-04
10809160532867HalyardBAAK106-15_0002BAAK106-152026-09-04
10809160532874HalyardKAFB009-16_0004KAFB009-162026-09-04
10809160532881HalyardFBCH130-04_0005FBCH130-042026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160532966HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160532973HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160532980HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160532997HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160533000HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160533017HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160533024HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160533031HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160533048HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160533055HalyardAVID MEDICAL, INC.LRO2026-09-05
10198956333420CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956395947CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956462977CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956486058CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956530744CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956531611CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956535985CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956541177CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956541702CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956542532CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956546509CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956546585CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956547285CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956548022CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956551763CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956552364CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956552401CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956553385CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956554399CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956554429CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04