Ø6.5mm x 55mm Pedicle Screw with Set Screw Package

GUDID B064XM21565551

XENCO MEDICAL LLC

Orthopaedic implant/trial-implant/sizer holder, single-use Orthopaedic implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use
Primary Device IDB064XM21565551
NIH Device Record Key800dbe09-668e-496c-9ee2-6a55406de2f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameØ6.5mm x 55mm Pedicle Screw with Set Screw Package
Version Model NumberXM-215-6555
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
HIBCCB064XM21565551 [Primary]

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[B064XM21565551]

Radiation Sterilization

[B064XM21565551]

Radiation Sterilization

[B064XM21565551]

Radiation Sterilization

[B064XM21565551]

Radiation Sterilization

[B064XM21565551]

Radiation Sterilization

[B064XM21565551]

Radiation Sterilization

[B064XM21565551]

Radiation Sterilization

[B064XM21565551]

Radiation Sterilization

[B064XM21565551]

Radiation Sterilization

[B064XM21565551]

Radiation Sterilization

[B064XM21565551]

Radiation Sterilization

[B064XM21565551]

Radiation Sterilization

[B064XM21565551]

Radiation Sterilization

[B064XM21565551]

Radiation Sterilization

[B064XM21565551]

Radiation Sterilization

[B064XM21565551]

Radiation Sterilization

[B064XM21565551]

Radiation Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-06
Device Publish Date2015-10-27

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