MED-J

GUDID 18054301668703

Bone Marrow Biopsy and Aspiration System 13G x 9 cm

MEDAX SRL UNIPERSONALE

Bone marrow biopsy needle, single-use
Primary Device ID18054301668703
NIH Device Record Key259bdd0b-a060-465b-9a28-caa0298ef838
Commercial Distribution StatusIn Commercial Distribution
Brand NameMED-J
Version Model NumberXJ13090-00
Company DUNS440211428
Company NameMEDAX SRL UNIPERSONALE
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108054301668706 [Primary]
GS118054301668703 [Package]
Contains: 08054301668706
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNWInstrument, Biopsy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-15
Device Publish Date2020-07-07

On-Brand Devices [MED-J]

18054301668703Bone Marrow Biopsy and Aspiration System 13G x 9 cm
18054301668697Bone Marrow Biopsy and Aspiration System 13G x 5 cm
18054301668680Bone Marrow Biopsy and Aspiration System 11G x 15 cm
18054301668673Bone Marrow Biopsy and Aspiration System 11G x 10 cm
18054301668666Bone Marrow Biopsy and Aspiration System 8G x 10 cm

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