FDA.reportPublic FDA data

AVID TruCustom

Primary DI
20809160105624
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
ADVH066-11_0003
Published
2016-09-19
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

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
20809160105624PackageGS12In Commercial Distribution
10809160105627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916010562420809160105624
1080916010562710809160105627

GMDN Terms#

Term, Definition table
TermDefinition
Flexible-tip ultrasound laparoscopeAn electronic endoscope with a flexible distal tip, combined with an ultrasound probe, intended for the visual examination, treatment, and ultrasonic imaging of the abdominal/retroperitoneal cavity and its organs. It is inserted through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy. Anatomical images are transmitted to the user through a fibreoptic bundle or a video system and the ultrasound probe. The abdominal wall is distended using a gas distention device. The probe may be built-in or inserted through a dedicated channel so that its distal tip is positioned adjacent to the targeted organ. 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
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
10809160521878HalyardWBAM040-06_0005WBAM040-062026-05-27
10809160521885HalyardNAFB074-03_0006NAFB074-032026-05-27
10809160521892HalyardNAFB062-08_0002NAFB062-082026-05-27
10809160521908HalyardAKCR19-02_0005AKCR19-022026-05-27
10809160521915HalyardWINN104-09_0005WINN104-092026-05-27
10809160521922HalyardJACK401-09_0005JACK401-092026-05-27
10809160521939HalyardKDAU209-02_0012KDAU209-022026-05-27
10809160521946HalyardTPAH21-01_0011TPAH21-012026-05-27
10809160521953HalyardKDAU229-01_0007KDAU229-012026-05-27
10809160521960HalyardEABF016-06_0006EABF016-062026-05-27
10809160521977HalyardHHTK38-01_0010HHTK38-012026-05-27
10809160521984HalyardUFCF028-01_0008UFCF028-012026-05-27
10809160521991HalyardSGMN13-03_0009SGMN13-032026-05-27
10809160522004HalyardDUUE43-02_0010DUUE43-022026-05-27
10809160522011HalyardOSSP27-01_0009OSSP27-012026-05-27
10809160522028HalyardDUUR35-01_0005DUUR35-012026-05-27
10809160522035HALYARDAMCH001-02AMCH001-022026-05-27
10809160521816HalyardDUOH90-03_0001DUOH90-032026-05-26
10809160521823HalyardDUOH90-03_0004DUOH90-032026-05-26
10809160521830HalyardVAMH014-07_0007VAMH014-072026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160521915HalyardAVID MEDICAL, INC.OKV2026-05-27
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
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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