2.4 mm Cortical Screw, Self-tapping, Star Head, 8mm length

GUDID 08903993538838

Ti-1242.08S2.4 mm Cortical Screw, Self-tapping, Star Head, 8mm length

Auxein Medical Private Limited

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID08903993538838
NIH Device Record Keyd69fc5db-bd75-4558-86bc-faf296f651c3
Commercial Distribution StatusIn Commercial Distribution
Brand Name2.4 mm Cortical Screw, Self-tapping, Star Head, 8mm length
Version Model NumberTi-1242.08S
Company DUNS872194615
Company NameAuxein Medical Private Limited
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+91 9910643638
Emailinfo@auxein.com
Phone+91 9910643638
Emailinfo@auxein.com
Phone+91 9910643638
Emailinfo@auxein.com
Phone+91 9910643638
Emailinfo@auxein.com
Phone+91 9910643638
Emailinfo@auxein.com
Phone+91 9910643638
Emailinfo@auxein.com
Phone+91 9910643638
Emailinfo@auxein.com
Phone+91 9910643638
Emailinfo@auxein.com
Phone+91 9910643638
Emailinfo@auxein.com
Phone+91 9910643638
Emailinfo@auxein.com
Phone+91 9910643638
Emailinfo@auxein.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108903993538838 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-09
Device Publish Date2022-04-29

On-Brand Devices [2.4 mm Cortical Screw, Self-tapping, Star Head, 8mm length]

08903993538838Ti-1242.08S2.4 mm Cortical Screw, Self-tapping, Star Head, 8mm length
089039933179142.4 mm Cortical Screw, Self-tapping, Star Head, 8mm length

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