SLEEVE HANDLE 303-0001

GUDID 00816950029929

SLEEVE HANDLE

SMV SCIENTIFIC LLC

Orthopaedic implant inserter/extractor, reusable
Primary Device ID00816950029929
NIH Device Record Key9f7d4f03-5f93-46e6-93f6-723572c480d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameSLEEVE HANDLE
Version Model Number303-0001
Catalog Number303-0001
Company DUNS089645059
Company NameSMV SCIENTIFIC LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Conditional
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

Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816950029929 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HXXScrewdriver
MDMInstrument, Manual, Surgical, General Use

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816950029929]

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[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

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[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


[00816950029929]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-24
Device Publish Date2022-02-16

Devices Manufactured by SMV SCIENTIFIC LLC

00810074300001 - 4.0 x 12mm Screw Super Fastener, ST2023-06-20 4.0 x 12mm Screw Super Fastener, ST
00810074300018 - 4.0 x 14mm Screw Super Fastener, ST2023-06-20 4.0 x 14mm Screw Super Fastener, ST
00810074300025 - 4.0 x 16mm Screw Super Fastener, ST2023-06-20 4.0 x 16mm Screw Super Fastener, ST
00810074300032 - 4.0 x 18mm Screw Super Fastener, ST2023-06-20 4.0 x 18mm Screw Super Fastener, ST
00810074300049 - 4.0 x 20mm Screw Super Fastener, ST2023-06-20 4.0 x 20mm Screw Super Fastener, ST
00810074300056 - 4.0 x 22mm Screw Super Fastener, ST2023-06-20 4.0 x 22mm Screw Super Fastener, ST
00810074300063 - 4.0 x 24mm Screw Super Fastener, ST2023-06-20 4.0 x 24mm Screw Super Fastener, ST
00810074300070 - 4.0 x 26mm Screw Super Fastener, ST2023-06-20 4.0 x 26mm Screw Super Fastener, ST

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