FDA.report

AVID TruCustom

Primary DI
20809160209551
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
VAML025-03_0003
Catalog number
VAML025-03
Published
2018-09-14
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

Related Records

Contact Domains

Product Codes

CodeName
OKVObstetrical kit

Product Code Classifications

CodeDeviceSpecialtyClass
OKVObstetrical KitObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20809160209551PackageGS14In Commercial Distribution
10809160209554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080916020955120809160209551
1080916020955410809160209554

GMDN Terms

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

Contacts

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
false

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