StabiliT Second Fracture Kit 1436

GUDID 00850696006509

Dfine, Inc.

Orthopaedic cement, non-medicated
Primary Device ID00850696006509
NIH Device Record Key02071cfb-93ec-4c7a-9523-229b23965508
Commercial Distribution StatusIn Commercial Distribution
Brand NameStabiliT Second Fracture Kit
Version Model Number1436
Catalog Number1436
Company DUNS169957607
Company NameDfine, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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
GS100850696006509 [Primary]

FDA Product Code

NDNCement, Bone, Vertebroplasty

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-03-19
Device Publish Date2015-11-02

On-Brand Devices [StabiliT Second Fracture Kit]

008506960065161666
008506960065091436
008506960064001436-01
008506960063941666-01

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