Ga-mma Nail

GUDID 08903993367483

Ø10.5mm Cephalic Screw For Ga-mma Nail, Length 70mm, Titanium

Auxein Medical Private Limited

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID08903993367483
NIH Device Record Key51690e1e-2e1b-4c4c-8a6a-933fe6e6685e
Commercial Distribution StatusIn Commercial Distribution
Brand NameGa-mma Nail
Version Model NumberTI-600C-10.5-070
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+919910643638
Emailinfo@auxein.com
Phone+919910643638
Emailinfo@auxein.com
Phone+919910643638
Emailinfo@auxein.com
Phone+919910643638
Emailinfo@auxein.com
Phone+919910643638
Emailinfo@auxein.com
Phone+919910643638
Emailinfo@auxein.com
Phone+919910643638
Emailinfo@auxein.com
Phone+919910643638
Emailinfo@auxein.com
Phone+919910643638
Emailinfo@auxein.com
Phone+919910643638
Emailinfo@auxein.com
Phone+919910643638
Emailinfo@auxein.com
Phone+919910643638
Emailinfo@auxein.com
Phone+919910643638
Emailinfo@auxein.com
Phone+919910643638
Emailinfo@auxein.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108903993367483 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08903993367483]

Moist Heat or Steam Sterilization

[08903993367483]

Moist Heat or Steam Sterilization

[08903993367483]

Moist Heat or Steam Sterilization

[08903993367483]

Moist Heat or Steam Sterilization

[08903993367483]

Moist Heat or Steam Sterilization

[08903993367483]

Moist Heat or Steam Sterilization

[08903993367483]

Moist Heat or Steam Sterilization

[08903993367483]

Moist Heat or Steam Sterilization

[08903993367483]

Moist Heat or Steam Sterilization

[08903993367483]

Moist Heat or Steam Sterilization

[08903993367483]

Moist Heat or Steam Sterilization

[08903993367483]

Moist Heat or Steam Sterilization

[08903993367483]

Moist Heat or Steam Sterilization

[08903993367483]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-02
Device Publish Date2020-10-23

On-Brand Devices [Ga-mma Nail]

08903993373866Inner Screw For Ga-mma Nail Type-II, Titanium
08903993373842End Cap For Ga-mma Nail Type-II, Length 15mm, Titanium
08903993373835End Cap For Ga-mma Nail Type-II, Length 10mm, Titanium
08903993373828End Cap For Ga-mma Nail Type-II, Length 5mm, Titanium
08903993373811End Cap For Ga-mma Nail Type-II, Length 0mm, Titanium
08903993371770Ø6.4mm Cannulated Anti-Rotation Screw, Length 115mm, Titanium (For Anti-Rotation Ga-mma Nail)
08903993371749Ø6.4mm Cannulated Anti-Rotation Screw, Length 100mm, Titanium (For Anti-Rotation Ga-mma Nail)
08903993371732Ø6.4mm Cannulated Anti-Rotation Screw, Length 95mm, Titanium (For Anti-Rotation Ga-mma Nail)
08903993371725Ø6.4mm Cannulated Anti-Rotation Screw, Length 90mm, Titanium (For Anti-Rotation Ga-mma Nail)
08903993371718Ø6.4mm Cannulated Anti-Rotation Screw, Length 85mm, Titanium (For Anti-Rotation Ga-mma Nail)
08903993371701Ø6.4mm Cannulated Anti-Rotation Screw, Length 80mm, Titanium (For Anti-Rotation Ga-mma Nail)
08903993371688Ø6.4mm Cannulated Anti-Rotation Screw, Length 70mm, Titanium (For Anti-Rotation Ga-mma Nail)
08903993371671Ø6.4mm Cannulated Anti-Rotation Screw, Length 65mm, Titanium (For Anti-Rotation Ga-mma Nail)
08903993371664Ø6.4mm Cannulated Anti-Rotation Screw, Length 60mm, Titanium
08903993371503Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 80mm, Titanium
08903993371480Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 70mm, Titanium
08903993371435Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 56mm, Titanium
08903993371428Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 54mm, Titanium
08903993371411Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 50mm, Titanium
08903993371404Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 48mm, Titanium
08903993371381Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 44mm, Titanium
08903993371329Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 32mm, Titanium
08903993371312Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 30mm, Titanium
08903993371305Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 28mm, Titanium
08903993367575Ø10.5mm Cephalic Screw For Ga-mma Nail, Length 120mm, Titanium
08903993367568Ø10.5mm Cephalic Screw For Ga-mma Nail, Length 115mm, Titanium
08903993367551Ø10.5mm Cephalic Screw For Ga-mma Nail, Length 110mm, Titanium
08903993367544Ø10.5mm Cephalic Screw For Ga-mma Nail, Length 100mm, Titanium
08903993367537Ø10.5mm Cephalic Screw For Ga-mma Nail, Length 95mm, Titanium
08903993367520Ø10.5mm Cephalic Screw For Ga-mma Nail, Length 90mm, Titanium
08903993367513Ø10.5mm Cephalic Screw For Ga-mma Nail, Length 85mm, Titanium
08903993367506Ø10.5mm Cephalic Screw For Ga-mma Nail, Length 80mm, Titanium
08903993367490Ø10.5mm Cephalic Screw For Ga-mma Nail, Length 75mm, Titanium
08903993367483Ø10.5mm Cephalic Screw For Ga-mma Nail, Length 70mm, Titanium
08903993363614Ø6.4mm Cannulated Anti-Rotation Screw, Length 120mm, Titanium (For Anti-Rotation Ga-mma Nail)
08903993363584Ø10.5mm Cephalic Screw For Ga-mma Nail, Length 105mm, Titanium
08903993363577Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 60mm, Titanium
08903993363560Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 58mm, Titanium
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.