Filler Kit

GUDID 04250203940702

Joline GmbH & Co. KG

Bone grafting cannula
Primary Device ID04250203940702
NIH Device Record Key1757d66d-cbd8-4240-b491-b851c8de84d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameFiller Kit
Version Model NumberUS7ZN0000
Company DUNS342087108
Company NameJoline GmbH & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104250203940702 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXArthroscope

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-24
Device Publish Date2020-08-14

Devices Manufactured by Joline GmbH & Co. KG

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04250203940405 - Best Kit Mod. One Pedicle Stop'n GO 2 x 8 mm2020-08-24
04250203940436 - Best Kit SpeedTrack Stop'n GO 2 x 8 mm2020-08-24
04250203940443 - Best Kit RapidIntro Bevel Tip Stop'n GO 2 x 8 mm2020-08-24
04250203940450 - Best Kit Stop'n GO 2 x 8 mm2020-08-24
04250203940467 - Best Kit SpeedTrack Stop'n GO 2 x 8 mm2020-08-24
04250203940474 - Best Kit RapidIntro Bevel Tip Stop'n GO 2 x 8 mm2020-08-24
04250203940481 - Best Kit Mod. One Pedicle Stop'n GO 2 x 8 mm2020-08-24

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