IM Nail Dispenser Mold

GUDID 10860003533205

Bonesetter Holdings, LLC

Orthopaedic cement injection cannula
Primary Device ID10860003533205
NIH Device Record Keybab3deec-45cb-4e58-9fe5-ca109ff14045
Commercial Distribution StatusIn Commercial Distribution
Brand NameIM Nail Dispenser Mold
Version Model Number01-IMABC11
Company DUNS117402625
Company NameBonesetter Holdings, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100860003533208 [Primary]
GS110860003533205 [Package]
Contains: 00860003533208
Package: Box [4 Units]
In Commercial Distribution

FDA Product Code

OARInjector, Vertebroplasty (Does Not Contain Cement)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-24
Device Publish Date2020-12-16

On-Brand Devices [IM Nail Dispenser Mold]

1086000353320501-IMABC11
1086000353321201-IMABC13
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