Steel T Handle

GUDID 00810028397750

Medshape, Inc.

External orthopaedic fixation system, reusable
Primary Device ID00810028397750
NIH Device Record Keyd8f75fd0-4c17-4169-8c26-8d2d73e3841b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSteel T Handle
Version Model NumberDNE-9000-TH-ST
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810028397750 [Primary]

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810028397750]

Moist Heat or Steam Sterilization


[00810028397750]

Moist Heat or Steam Sterilization


[00810028397750]

Moist Heat or Steam Sterilization


[00810028397750]

Moist Heat or Steam Sterilization


[00810028397750]

Moist Heat or Steam Sterilization


[00810028397750]

Moist Heat or Steam Sterilization


[00810028397750]

Moist Heat or Steam Sterilization


[00810028397750]

Moist Heat or Steam Sterilization


[00810028397750]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-17
Device Publish Date2024-07-09

Devices Manufactured by Medshape, Inc.

00810028395855 - Half pin - 3 x 100mm with 30mm thread2024-07-17
00810028395862 - Half pin - 3 x 120mm with 25mm thread2024-07-17
00810028395879 - Half pin - 3 x 120mm with 30mm thread2024-07-17
00810028395893 - Half pin - 4 x 180mm with 25mm thread2024-07-17
00810028395930 - Half pin - 5 x 180mm with 25mm thread2024-07-17
00810028395978 - Half pin - 6 x 180mm with 35mm thread2024-07-17
00810028395992 - Half pin - 4 x 180mm with 45mm thread, stepped tip2024-07-17
00810028396005 - Half pin - 5 x 180mm with 50mm thread, stepped tip2024-07-17

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