FDA.report

Techna-Cut™ Biopsy Needle

Primary DI
20886333003444
Brand
Techna-Cut™ Biopsy Needle
Company
ARGON MEDICAL DEVICES, INC.
Model
TCBN1807X
Catalog number
TCBN1807X
Device description
Techna-Cut™ Biopsy Needle 18ga x 7cm
Published
2016-09-13
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
20886333003444PackageGS110In Commercial Distribution
00886333003440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633300344420886333003444
00886333003440008863330034408863330034400886333003440

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
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry and Away from Sunlight

Sterilization Methods

Method

Contacts

PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags

DUNS number
140727624
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
true
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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