Fixed Screw Driver Handle, 1.7mm

GUDID 00810054090991

Fixed Screw Driver Handle, 1.7mm

AVANTI ORTHOPAEDICS LLC

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00810054090991
NIH Device Record Keyb5f83c81-6264-490f-934e-011f8fef1e95
Commercial Distribution StatusIn Commercial Distribution
Brand NameFixed Screw Driver Handle, 1.7mm
Version Model NumberFH17
Company DUNS043505370
Company NameAVANTI ORTHOPAEDICS LLC
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 Usefalse
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

Phone610 316 7345
Emailag.wieczorek.87@gmail.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810054090991 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810054090991]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-02-19
Device Publish Date2020-06-18

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