PrimoCut 415S120150

GUDID 04048223128954

Side-notch biopsy gun handpiece/needle

Primary Device ID	04048223128954
NIH Device Record Key	4ecb0d13-3c4a-4b30-8feb-181a2787134d
Commercial Distribution Status	In Commercial Distribution
Brand Name	PrimoCut
Version Model Number	415S120150
Catalog Number	415S120150
Company DUNS	317654283
Company Name	Pajunk GmbH Medizintechnologie
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius

Device Issuing Agency	Device ID
GS1	04048223127063 [Primary]
GS1	04048223128954 [Package] Contains: 04048223127063 Package: [10 Units] In Commercial Distribution

MJG	Device, percutaneous, biopsy

Steralize Prior To Use	false
Device Is Sterile	true