OS2®-C

GUDID 03760225711163

IN2BONES

Orthopaedic bone staple, non-adjustable
Primary Device ID03760225711163
NIH Device Record Key05264df5-00ae-427a-9bd7-86e674e00365
Commercial Distribution StatusIn Commercial Distribution
Brand NameOS2®-C
Version Model NumberT30 SP150
Company DUNS263616749
Company NameIN2BONES
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+33472292626
Emailcontact@in2bones.com
Phone+33472292626
Emailcontact@in2bones.com
Phone+33472292626
Emailcontact@in2bones.com
Phone+33472292626
Emailcontact@in2bones.com
Phone+33472292626
Emailcontact@in2bones.com
Phone+33472292626
Emailcontact@in2bones.com
Phone+33472292626
Emailcontact@in2bones.com
Phone+33472292626
Emailcontact@in2bones.com
Phone+33472292626
Emailcontact@in2bones.com
Phone+33472292626
Emailcontact@in2bones.com
Phone+33472292626
Emailcontact@in2bones.com
Phone+33472292626
Emailcontact@in2bones.com
Phone+33472292626
Emailcontact@in2bones.com
Phone+33472292626
Emailcontact@in2bones.com
Phone+33472292626
Emailcontact@in2bones.com
Phone+33472292626
Emailcontact@in2bones.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS103760225711163 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDRStaple, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-11-23
Device Publish Date2016-03-23

On-Brand Devices [OS2®-C]

03760225711163T30 SP150
03760225711156T30 SP130
03760225711149T30 SP110

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.