FDA.report

VACORA®

Primary DI
10801741079310
Brand
VACORA®
Company
Bard Peripheral Vascular, Inc.
Model
VB10118
Catalog number
VB10118
Device description
VACORA® Vacuum Assisted Biopsy System, Biopsy Probe, 10G x 118mm
Published
2016-09-21
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
KNWINSTRUMENT, BIOPSY

Product Code Classifications

CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10801741079310PackageGS15In Commercial Distribution
00801741079313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174107931010801741079310
00801741079313008017410793138017410793130801741079313

GMDN Terms

TermDefinition
Soft-tissue biopsy needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to percutaneously obtain a specimen of soft tissue, typically for histopathological examination. The device is usually attached to a syringe for the aspiration of the specimen; it is available in a variety of lengths, diameters (bores), and tip configurations (e.g., straight or curved). This is a single-use device.

Device Sizes

TypeValueUnit
Length118Millimeter
Needle Gauge10Gauge

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)321-4254medical.services@crbard.com

Regulatory Flags

DUNS number
135057938
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
false
Sterilization required before use
false

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