FDA.reportPublic FDA data

AVID TruCustom

Primary DI
20809160233792
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
NAFB038-01_0009
Catalog number
NAFB038-01
Published
2019-04-03
Public version status
New
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
OKVObstetrical kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKVObstetrical KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160233792PackageGS12In Commercial Distribution
10809160233795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916023379220809160233792
1080916023379510809160233795

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

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
true
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160521816HalyardDUOH90-03_0001DUOH90-032026-05-26
10809160521823HalyardDUOH90-03_0004DUOH90-032026-05-26
10809160521830HalyardVAMH014-07_0007VAMH014-072026-05-26
10809160521847HalyardARMC007-02_0007ARMC007-022026-05-26
10809160521731HalyardWINN122-09_0004WINN122-092026-05-22
10809160521762HalyardUSAR061-08_0004USAR061-082026-05-22
10809160521779HalyardWINN112-06_0014WINN112-062026-05-22
10809160521786HalyardUIPP85-02UIPP85-022026-05-22
10809160521793HalyardWINN112-06_0002WINN112-062026-05-22
10809160521809HalyardESFS76-01_0007ESFS76-012026-05-22
10809160521700HalyardDULP98-02_0001DULP98-022026-05-21
10809160521717HalyardLHMB9513-01_0004LHMB9513-012026-05-21
10809160521724HalyardNIHB0021-13_0003NIHB0021-132026-05-21
10809160521649HalyardNIHB0009-11_0007NIHB0009-112026-05-20
10809160521656HalyardNIHB0021-13_0011NIHB0021-132026-05-20
10809160521663HalyardNIHB0026-10_0003NIHB0026-102026-05-20
10809160521670HalyardNIHB0036-08_0006NIHB0036-082026-05-20
10809160521687HalyardNIHB0024-08_0006NIHB0024-082026-05-20
10809160521694HalyardWINN121-11_0002WINN121-112026-05-20
10809160521618HalyardSLCL55-02_0002SLCL55-022026-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489991543Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-10-15
10193489214284Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489215823Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489410211Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489412475Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489413014Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489413809Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489413984Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489419931Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489421637Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489424218Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489425758Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489426694Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489427516Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489428605Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489430660Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489431643Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489445053Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489447002Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489454505Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489454512Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489455076Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489455663Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489420708Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-04-30
10193489429442Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2022-09-04
10193489344844Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2022-08-04
10195327132132Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2022-08-04
10195327133320Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2022-08-04
10193489424607Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2022-07-17
10193489376456Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2022-06-12