FIX'IN

GUDID 03701045242178

Self-drilling screw Ø2.0mm L18mm

BIOTECH DENTAL

Craniofacial bone screw, non-bioabsorbable
Primary Device ID03701045242178
NIH Device Record Keye46b41ed-0842-4303-a344-15aab9e90ddb
Commercial Distribution StatusIn Commercial Distribution
Brand NameFIX'IN
Version Model NumberPV2018
Company DUNS265382983
Company NameBIOTECH DENTAL
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Conditional
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

Phone8662775662
Emailinfo@biotechdentalusa.com
Phone8662775662
Emailinfo@biotechdentalusa.com
Phone8662775662
Emailinfo@biotechdentalusa.com
Phone8662775662
Emailinfo@biotechdentalusa.com
Phone8662775662
Emailinfo@biotechdentalusa.com
Phone8662775662
Emailinfo@biotechdentalusa.com
Phone8662775662
Emailinfo@biotechdentalusa.com
Phone8662775662
Emailinfo@biotechdentalusa.com
Phone8662775662
Emailinfo@biotechdentalusa.com
Phone8662775662
Emailinfo@biotechdentalusa.com
Phone8662775662
Emailinfo@biotechdentalusa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103701045242178 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03701045242178]

Moist Heat or Steam Sterilization


[03701045242178]

Moist Heat or Steam Sterilization


[03701045242178]

Moist Heat or Steam Sterilization


[03701045242178]

Moist Heat or Steam Sterilization


[03701045242178]

Moist Heat or Steam Sterilization


[03701045242178]

Moist Heat or Steam Sterilization


[03701045242178]

Moist Heat or Steam Sterilization


[03701045242178]

Moist Heat or Steam Sterilization


[03701045242178]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-15
Device Publish Date2025-08-07