15mm x 13mm Cervical Rasps

GUDID B064XM12220051

15mm x 13mm Cervical Rasps

XENCO MEDICAL LLC

Bone file/rasp, manual
Primary Device IDB064XM12220051
NIH Device Record Key2cf39943-af00-4833-afcc-d7df22e063f6
Commercial Distribution StatusIn Commercial Distribution
Brand Name15mm x 13mm Cervical Rasps
Version Model NumberXM-122-2005
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

Customer Support Contacts

Phone858-202-1505
Emailsales@xencomedical.com
Phone858-202-1505
Emailsales@xencomedical.com
Phone858-202-1505
Emailsales@xencomedical.com
Phone858-202-1505
Emailsales@xencomedical.com
Phone858-202-1505
Emailsales@xencomedical.com
Phone858-202-1505
Emailsales@xencomedical.com
Phone858-202-1505
Emailsales@xencomedical.com
Phone858-202-1505
Emailsales@xencomedical.com
Phone858-202-1505
Emailsales@xencomedical.com
Phone858-202-1505
Emailsales@xencomedical.com
Phone858-202-1505
Emailsales@xencomedical.com
Phone858-202-1505
Emailsales@xencomedical.com
Phone858-202-1505
Emailsales@xencomedical.com
Phone858-202-1505
Emailsales@xencomedical.com
Phone858-202-1505
Emailsales@xencomedical.com
Phone858-202-1505
Emailsales@xencomedical.com
Phone858-202-1505
Emailsales@xencomedical.com
Phone858-202-1505
Emailsales@xencomedical.com
Phone858-202-1505
Emailsales@xencomedical.com
Phone858-202-1505
Emailsales@xencomedical.com
Phone858-202-1505
Emailsales@xencomedical.com
Phone858-202-1505
Emailsales@xencomedical.com
Phone858-202-1505
Emailsales@xencomedical.com
Phone858-202-1505
Emailsales@xencomedical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB064XM12220051 [Primary]

FDA Product Code

ODPIntervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[B064XM12220051]

Radiation Sterilization


[B064XM12220051]

Radiation Sterilization


[B064XM12220051]

Radiation Sterilization


[B064XM12220051]

Radiation Sterilization


[B064XM12220051]

Radiation Sterilization


[B064XM12220051]

Radiation Sterilization


[B064XM12220051]

Radiation Sterilization


[B064XM12220051]

Radiation Sterilization


[B064XM12220051]

Radiation Sterilization


[B064XM12220051]

Radiation Sterilization


[B064XM12220051]

Radiation Sterilization


[B064XM12220051]

Radiation Sterilization


[B064XM12220051]

Radiation Sterilization


[B064XM12220051]

Radiation Sterilization


[B064XM12220051]

Radiation Sterilization


[B064XM12220051]

Radiation Sterilization


[B064XM12220051]

Radiation Sterilization


[B064XM12220051]

Radiation Sterilization


[B064XM12220051]

Radiation Sterilization


[B064XM12220051]

Radiation Sterilization


[B064XM12220051]

Radiation Sterilization


[B064XM12220051]

Radiation Sterilization


[B064XM12220051]

Radiation Sterilization


[B064XM12220051]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-12-07
Device Publish Date2015-10-27

Devices Manufactured by XENCO MEDICAL LLC

B064XM3D31223121 - CancelleX™ 13mm x 12mm x 12mm x 12* Cervical Interbody2026-02-16
B064XM3D31225061 - CancelleX™ 15mm x 13mm x 6mm x 12* Cervical Interbody2026-02-16
B064XM3D31225071 - CancelleX™ 15mm x 13mm x 7mm x 12* Cervical Interbody2026-02-16
B064XM3D31225081 - CancelleX™ 15mm x 13mm x 8mm x 12* Cervical Interbody2026-02-16
B064XMPHCP610081 - 8mm One Level Cervical Plate2026-02-16
B064HB11200101 - Tube Guard2023-08-15
B064MPE010101 - Saratoga Cervical Brace2023-08-15
B064MPE010401 - Tahiti Lumbar Brace2023-08-15

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