Cartiva SCI Introducer INT-10

GUDID 00852897002113

Surgical Instrument- 10 mm Introducer

CARTIVA, INC

Orthopaedic prosthesis implantation instrument, reusable
Primary Device ID00852897002113
NIH Device Record Keyb2ec97e4-6fe1-4760-8301-3c40faa775ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameCartiva SCI Introducer
Version Model NumberINT-10
Catalog NumberINT-10
Company DUNS078582549
Company NameCARTIVA, 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 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

Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net

Device Identifiers

Device Issuing AgencyDevice ID
GS100852897002113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument
QBOInstruments Designed For Press-Fit Osteochondral Implants

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

[00852897002113]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-06-23
Device Publish Date2017-01-13

On-Brand Devices [Cartiva SCI Introducer]

00852897002113Surgical Instrument- 10 mm Introducer
00852897002106Surgical Instrument- 8 mm Introducer
00852897002052Surgical Instrument- 10 mm Introducer
00852897002045Surgical Instrument- 8 mm Introducer
00852897002977Surgical Instrument- 6 mm Introducer
00852897002946Surgical Instrument- 12 mm Introducer
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