FDA.report

DeltaCut Biopsy gun

Primary DI
04048223013182
Brand
DeltaCut Biopsy gun
Company
Pajunk GmbH Medizintechnologie
Model
304B000001
Catalog number
304B000001
Device description
DeltaCut Biopsy gun
Published
2019-03-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KNWINSTRUMENT, BIOPSY

Product Code Classifications

CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048223013182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048223013182040482230131824048223013182

GMDN Terms

TermDefinition
Biopsy gun handpieceA hand-operated, non-electronic, surgical instrument designed to be used with a dedicated disposable biopsy gun needle (not included) for the automatic extraction of a soft-tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It has a spring-loaded mechanism with a release trigger intended to accept and operate the cutting mechanism of a percutaneous biopsy needle. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(888)972-5865info@pajunk-usa.com

Regulatory Flags

DUNS number
317654283
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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