240mm Speed Frame Universal Joint Side

GUDID 00810028397002

Medshape, Inc.

Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID00810028397002
NIH Device Record Keyc2489ec6-8898-4a4d-bdfe-fb1d67d843e9
Commercial Distribution StatusIn Commercial Distribution
Brand Name240mm Speed Frame Universal Joint Side
Version Model NumberDNE-240-SFU
Company DUNS601306413
Company NameMedshape, Inc.
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810028397002 [Primary]

FDA Product Code

KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810028397002]

Moist Heat or Steam Sterilization


[00810028397002]

Moist Heat or Steam Sterilization


[00810028397002]

Moist Heat or Steam Sterilization


[00810028397002]

Moist Heat or Steam Sterilization


[00810028397002]

Moist Heat or Steam Sterilization


[00810028397002]

Moist Heat or Steam Sterilization


[00810028397002]

Moist Heat or Steam Sterilization


[00810028397002]

Moist Heat or Steam Sterilization


[00810028397002]

Moist Heat or Steam Sterilization


[00810028397002]

Moist Heat or Steam Sterilization


[00810028397002]

Moist Heat or Steam Sterilization


[00810028397002]

Moist Heat or Steam Sterilization


[00810028397002]

Moist Heat or Steam Sterilization


[00810028397002]

Moist Heat or Steam Sterilization


[00810028397002]

Moist Heat or Steam Sterilization


[00810028397002]

Moist Heat or Steam Sterilization


[00810028397002]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-10
Device Publish Date2024-05-31

Devices Manufactured by Medshape, Inc.

00810028395848 - Half Pin - 3mm x 100mm with 25mm Thread2024-07-02
00810028397712 - Rail T Handle (Red) Long with 9/64 Tool Shaft2024-07-02
00810028395886 - Collet - 3mm - Black 2024-06-10
00810028395909 - Collet - 4mm - Red2024-06-10
00810028395923 - Collet - 6mm - Green2024-06-10
00810028395947 - Collet - 6mm - Green2024-06-10
00810028395961 - Half Pin - 3mm x 100mm with 25mm Thread2024-06-10
00810028396012 - 4.0 x 300mm Transfixing Pin2024-06-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.