FDA.reportPublic FDA data

AVID TruCustom

Primary DI
20809160062125
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
ORHS014-02_0009
Catalog number
ORHS014-02
Published
2016-09-10
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

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
20809160062125PackageGS13In Commercial Distribution
10809160062128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916006212520809160062125
1080916006212810809160062128

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA general-purpose collection of various surgical instruments, dressings, and materials, including a pharmaceutical component, intended to be used to assist a range of surgical procedures across multiple clinical specialities. 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
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160522820HalyardSFSJACK455-05_0002SFSJACK455-052026-06-08
10809160522837HalyardSFSBMHU003-05_0001SFSBMHU003-052026-06-08
10809160522844HalyardSFSJACK435-09_0001SFSJACK435-092026-06-08
10809160522851HalyardBMHU003-05_0001BMHU003-052026-06-08
10809160522868HalyardSFSMSBM022-06_0001SFSMSBM022-062026-06-08
10809160522875HalyardMSBM030-06_0007MSBM030-062026-06-08
10809160522882HalyardMSBM022-06_0006MSBM022-062026-06-08
10809160522899HalyardJACK435-09_0005JACK435-092026-06-08
10809160522905HalyardSFSMSBM030-06_0002SFSMSBM030-062026-06-08
10809160522912HalyardJACK455-05_0001JACK455-052026-06-08
10809160522929HalyardSFSJCLC12-01_0001SFSJCLC12-012026-06-08
10809160522936HalyardSHAN453-04_0015SHAN453-042026-06-08
10809160522943HalyardBMHT030-05_0003BMHT030-052026-06-08
10809160522950HalyardMAMC229-22_0001MAMC229-222026-06-08
10809160522967HalyardACTK56-03_0008ACTK56-032026-06-08
10809160522974HalyardDGAL24-03_0007DGAL24-032026-06-08
10809160522981HalyardAVMD016-02_0005AVMD016-022026-06-08
10809160522998HalyardMEHY02O_0011MEHY02O2026-06-08
10809160523001HalyardMCBP83-02_0005MCBP83-022026-06-08
10809160523018HalyardMAMC213-09_0004MAMC213-092026-06-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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