TDX

GUDID 18257200016280

INSTRUMENT CASE ASSEMBLY

ORTHOFIX INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID18257200016280
NIH Device Record Key32d76e59-f148-43a6-a637-bf2d1aaefd2a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTDX
Version Model Number16-0001
Company DUNS927083808
Company NameORTHOFIX INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)527-0404
Email[email protected]

Device Identifiers

Device Issuing AgencyDevice ID
GS118257200016280 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18257200016280]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-11
Device Publish Date2020-02-03

On-Brand Devices [TDX]

18257200093793TDX STABILIATION SYSTEM INSTRUMENT CASE (16-0010)
18257200016280INSTRUMENT CASE ASSEMBLY

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