Cannulated Compression Screw w/ Hexalobular Drive, 3.2mm x 14mm Long

GUDID 00810054092308

Cannulated Compression Screw w/ Hexalobular Drive, 3.2mm x 14mm Long

AVANTI ORTHOPAEDICS LLC

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00810054092308
NIH Device Record Key0d55d5b4-27b9-41d7-b3e4-7fa7f7ee4b5d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCannulated Compression Screw w/ Hexalobular Drive, 3.2mm x 14mm Long
Version Model NumberCH3214
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 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

Phone610-316-7345
Emailinfo@avantiortho.com
Phone610-316-7345
Emailinfo@avantiortho.com
Phone610-316-7345
Emailinfo@avantiortho.com
Phone610-316-7345
Emailinfo@avantiortho.com
Phone610-316-7345
Emailinfo@avantiortho.com
Phone610-316-7345
Emailinfo@avantiortho.com
Phone610-316-7345
Emailinfo@avantiortho.com
Phone610-316-7345
Emailinfo@avantiortho.com
Phone610-316-7345
Emailinfo@avantiortho.com
Phone610-316-7345
Emailinfo@avantiortho.com
Phone610-316-7345
Emailinfo@avantiortho.com
Phone610-316-7345
Emailinfo@avantiortho.com
Phone610-316-7345
Emailinfo@avantiortho.com
Phone610-316-7345
Emailinfo@avantiortho.com
Phone610-316-7345
Emailinfo@avantiortho.com
Phone610-316-7345
Emailinfo@avantiortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810054092308 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810054092308]

Moist Heat or Steam Sterilization

[00810054092308]

Moist Heat or Steam Sterilization

[00810054092308]

Moist Heat or Steam Sterilization

[00810054092308]

Moist Heat or Steam Sterilization

[00810054092308]

Moist Heat or Steam Sterilization

[00810054092308]

Moist Heat or Steam Sterilization

[00810054092308]

Moist Heat or Steam Sterilization

[00810054092308]

Moist Heat or Steam Sterilization

[00810054092308]

Moist Heat or Steam Sterilization

[00810054092308]

Moist Heat or Steam Sterilization

[00810054092308]

Moist Heat or Steam Sterilization

[00810054092308]

Moist Heat or Steam Sterilization

[00810054092308]

Moist Heat or Steam Sterilization

[00810054092308]

Moist Heat or Steam Sterilization

[00810054092308]

Moist Heat or Steam Sterilization

[00810054092308]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-12
Device Publish Date2022-12-02

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