Rod Gripper 99715013

GUDID 03700780637881

Spinal instrument

CLARIANCE

Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID03700780637881
NIH Device Record Keya8b553cd-71d0-4108-a4aa-aa6fdbee2da5
Commercial Distribution StatusIn Commercial Distribution
Brand NameRod Gripper
Version Model Number99715013
Catalog Number99715013
Company DUNS296568400
Company NameCLARIANCE
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1 773 620 2111
Emails.chambat@clariance-spine.us
Phone1 773 620 2111
Emails.chambat@clariance-spine.us
Phone1 773 620 2111
Emails.chambat@clariance-spine.us
Phone1 773 620 2111
Emails.chambat@clariance-spine.us
Phone1 773 620 2111
Emails.chambat@clariance-spine.us
Phone1 773 620 2111
Emails.chambat@clariance-spine.us
Phone1 773 620 2111
Emails.chambat@clariance-spine.us
Phone1 773 620 2111
Emails.chambat@clariance-spine.us
Phone1 773 620 2111
Emails.chambat@clariance-spine.us
Phone1 773 620 2111
Emails.chambat@clariance-spine.us
Phone1 773 620 2111
Emails.chambat@clariance-spine.us

Device Identifiers

Device Issuing AgencyDevice ID
GS103700780637881 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03700780637881]

Moist Heat or Steam Sterilization


[03700780637881]

Moist Heat or Steam Sterilization


[03700780637881]

Moist Heat or Steam Sterilization


[03700780637881]

Moist Heat or Steam Sterilization


[03700780637881]

Moist Heat or Steam Sterilization


[03700780637881]

Moist Heat or Steam Sterilization


[03700780637881]

Moist Heat or Steam Sterilization


[03700780637881]

Moist Heat or Steam Sterilization


[03700780637881]

Moist Heat or Steam Sterilization


[03700780637881]

Moist Heat or Steam Sterilization


[03700780637881]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-27
Device Publish Date2020-10-19

Devices Manufactured by CLARIANCE

03700780644018 - Idys®- C ZP 3DTi2024-04-04 SCREW
03700780644025 - Idys®- C ZP 3DTi2024-04-04 SCREW
03700780644032 - Idys®- C ZP 3DTi2024-04-04 SCREW
03700780644049 - Idys®- C ZP 3DTi2024-04-04 SCREW
03700780644186 - Idys®- C ZP 3DTi2024-04-04 SCREW
03700780644193 - Idys®- C ZP 3DTi2024-04-04 SCREW
03700780644209 - Idys®- C ZP 3DTi2024-04-04 SCREW
03700780644216 - Idys®- C ZP 3DTi2024-04-04 SCREW

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