Precontoured Rod Ø5.5 mm x55 mm Package

GUDID B064XM21510551

XENCO MEDICAL LLC

Spinal implant trial
Primary Device IDB064XM21510551
NIH Device Record Key32295ead-0351-4afc-845f-8829d86bdf35
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrecontoured Rod Ø5.5 mm x55 mm Package
Version Model NumberXM-215-1055
Company DUNS079282130
Company NameXENCO MEDICAL LLC
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
HIBCCB064XM21510551 [Primary]

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[B064XM21510551]

Radiation Sterilization


[B064XM21510551]

Radiation Sterilization


[B064XM21510551]

Radiation Sterilization


[B064XM21510551]

Radiation Sterilization


[B064XM21510551]

Radiation Sterilization


[B064XM21510551]

Radiation Sterilization


[B064XM21510551]

Radiation Sterilization


[B064XM21510551]

Radiation Sterilization


[B064XM21510551]

Radiation Sterilization


[B064XM21510551]

Radiation Sterilization


[B064XM21510551]

Radiation Sterilization


[B064XM21510551]

Radiation Sterilization


[B064XM21510551]

Radiation Sterilization


[B064XM21510551]

Radiation Sterilization


[B064XM21510551]

Radiation Sterilization


[B064XM21510551]

Radiation Sterilization


[B064XM21510551]

Radiation Sterilization


[B064XM21510551]

Radiation Sterilization


[B064XM21510551]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-02-07
Device Publish Date2015-10-30

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