K-Wire 1.1mm, Smooth, Single Trocar EX01-0028

GUDID 00850015496264

K-Wire 1.1mm, Smooth, Single Trocar

Osteocentric Technologies, Inc.

Orthopaedic bone wire
Primary Device ID00850015496264
NIH Device Record Key4cebfc52-4639-4fc2-aec7-cb3c9f7f34b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameK-Wire 1.1mm, Smooth, Single Trocar
Version Model NumberEX01-0028
Catalog NumberEX01-0028
Company DUNS089645059
Company NameOsteocentric Technologies, 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 Batchfalse
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

Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com

Device Dimensions

Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter
Guidewire Diameter1.1 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850015496264 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTYPin, Fixation, Smooth

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

[00850015496264]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-08-16
Device Publish Date2020-06-11

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