SeaSpine NewPort Spinal System 91-8116

GUDID 10889981129828

8.5/9.5mm Screw Inserter Sleeve, Containing

SEASPINE ORTHOPEDICS CORPORATION

Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable
Primary Device ID10889981129828
NIH Device Record Key78b116bf-11e9-473a-8007-0e57dcb16c61
Commercial Distribution StatusIn Commercial Distribution
Brand NameSeaSpine NewPort Spinal System
Version Model Number91-8116
Catalog Number91-8116
Company DUNS079840876
Company NameSEASPINE ORTHOPEDICS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS110889981129828 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10889981129828]

Moist Heat or Steam Sterilization


[10889981129828]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-12

On-Brand Devices [SeaSpine NewPort Spinal System]

10889981138813Newport 4.75 X 50mm Double Lead Screw
10889981138806Newport 4.75 X 45mm Double Lead Screw
10889981138790Newport 4.75 X 40mm Double Lead Screw
10889981138783Newport 4.75 X 35mm Double Lead Screw
10889981138776Newport 4.75 X 30mm Double Lead Screw
108899811298288.5/9.5mm Screw Inserter Sleeve, Containing
10889981125776Newport 4.75mm Screw Caddy
10889981125769Newport 9.5mm Screw Caddy
10889981125752Newport Extension Tray

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