2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Left), 6 he

GUDID 08903993391105

2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Left), 6 head Holes,7 holes

Auxein Medical Private Limited

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID08903993391105
NIH Device Record Keyac13a255-8866-470a-8258-e53682e7db5b
Commercial Distribution StatusIn Commercial Distribution
Brand Name2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Left), 6 he
Version Model NumberTi-546.207L
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+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
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
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
Phone+91 9910643638
Emailinfo@auxein.com
Phone+91 9910643638
Emailinfo@auxein.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108903993391105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

[08903993391105]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-09
Device Publish Date2022-04-30

On-Brand Devices [2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Left), 6 he]

089039935374422.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Left), 6 head Holes,8 holes
089039935374352.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Left), 6 head Holes,7 holes
089039935374282.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Left), 6 head Holes,6 holes
089039935374112.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Left), 6 head Holes,5 holes
089039935374042.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Left), 6 head Holes,4 holes
089039935373982.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Left), 6 head Holes,3 holes
089039935373812.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Left), 6 head Holes,2 holes
089039933911122.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Left), 6 head Holes,8 holes
089039933911052.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Left), 6 head Holes,7 holes
089039933910992.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Left), 6 head Holes,6 holes
089039933590442.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Left), 6 head Holes,5 holes
089039933590372.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Left), 6 head Holes,4 holes
089039933588702.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Left), 6 head Holes,3 holes
089039933588632.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Left), 6 head Holes,2 holes
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