Cranial Fusion 9355-14

GUDID 00190837085377

Life Spine, Inc.

Spinal fixation plate, non-bioabsorbable
Primary Device ID00190837085377
NIH Device Record Key3ac98a53-a22c-496b-9c68-1d005f66b9f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameCranial Fusion
Version Model Number9355-14
Catalog Number9355-14
Company DUNS183641617
Company NameLife Spine, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100190837085377 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837085377]

Moist Heat or Steam Sterilization


[00190837085377]

Moist Heat or Steam Sterilization


[00190837085377]

Moist Heat or Steam Sterilization


[00190837085377]

Moist Heat or Steam Sterilization


[00190837085377]

Moist Heat or Steam Sterilization


[00190837085377]

Moist Heat or Steam Sterilization


[00190837085377]

Moist Heat or Steam Sterilization


[00190837085377]

Moist Heat or Steam Sterilization


[00190837085377]

Moist Heat or Steam Sterilization


[00190837085377]

Moist Heat or Steam Sterilization


[00190837085377]

Moist Heat or Steam Sterilization


[00190837085377]

Moist Heat or Steam Sterilization


[00190837085377]

Moist Heat or Steam Sterilization


[00190837085377]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-15
Device Publish Date2019-11-07

On-Brand Devices [Cranial Fusion]

001908370853779355-14
001908370853609355-12
001908370853539355-10
001908370853469355-08
001908370853399355-06
001908370853229350-14
001908370853159350-13
001908370853089350-12
001908370852929350-11
001908370852859350-10
00190837085278117-1109
00190837085261117-1108
00190837085254117-1107
00190837085247117-1106
00190837085230114-377-5
00190837085223114-377-4
00190837085216114-377-3
00190837085209114-377-2
00190837085193114-377-1
00190837085186113-106

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