K-wires WIRE-0.7/100

GUDID 00842188129759

K-Wire 0.7, 100mm

Trimed, INC.

Orthopaedic intraoperative positioning pin, single-use
Primary Device ID00842188129759
NIH Device Record Key202e6a9a-271e-4e95-a712-54c3b95654b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameK-wires
Version Model NumberWIRE-0.7/100
Catalog NumberWIRE-0.7/100
Company DUNS138041277
Company NameTrimed, 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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com
Phone+1(661)255-7406
Emailinfo@trimedortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100842188129759 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NDLPIN, FIXATION, SMOOTH, METALLIC

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00842188129759]

Moist Heat or Steam Sterilization


[00842188129759]

Moist Heat or Steam Sterilization


[00842188129759]

Moist Heat or Steam Sterilization


[00842188129759]

Moist Heat or Steam Sterilization


[00842188129759]

Moist Heat or Steam Sterilization


[00842188129759]

Moist Heat or Steam Sterilization


[00842188129759]

Moist Heat or Steam Sterilization


[00842188129759]

Moist Heat or Steam Sterilization


[00842188129759]

Moist Heat or Steam Sterilization


[00842188129759]

Moist Heat or Steam Sterilization


[00842188129759]

Moist Heat or Steam Sterilization


[00842188129759]

Moist Heat or Steam Sterilization


[00842188129759]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-01
Device Publish Date2025-04-23

Devices Manufactured by Trimed, INC.

00842188128752 - Drills2025-05-02 Drill 1.5, 95mm Cannulated
00842188128387 - CannCompScrew 2.0mm (SelfDrill)2025-05-01 Self-Drill CCScrew LThd 2.0, 08mm
00842188128394 - CannCompScrew 2.0mm (SelfDrill)2025-05-01 Self-Drill CCScrew LThd 2.0, 09mm
00842188128400 - CannCompScrew 2.0mm (SelfDrill)2025-05-01 Self-Drill CCScrew LThd 2.0, 10mm
00842188128417 - CannCompScrew 2.0mm (SelfDrill)2025-05-01 Self-Drill CCScrew LThd 2.0, 11mm
00842188128424 - CannCompScrew 2.0mm (SelfDrill)2025-05-01 Self-Drill CCScrew LThd 2.0, 12mm
00842188128431 - CannCompScrew 2.0mm (SelfDrill)2025-05-01 Self-Drill CCScrew LThd 2.0, 13mm
00842188128448 - CannCompScrew 2.0mm (SelfDrill)2025-05-01 Self-Drill CCScrew LThd 2.0, 14mm

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