Cartiva SCI Placer PLC-08-US

GUDID 00852897002083

Surgical Instrument- 8 mm Placer

CARTIVA, INC

Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID00852897002083
NIH Device Record Key078ff53e-3c70-441b-888d-8b0a741320b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameCartiva SCI Placer
Version Model NumberPLC-08-US
Catalog NumberPLC-08-US
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100852897002083 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00852897002083]

Moist Heat or Steam Sterilization

[00852897002083]

Moist Heat or Steam Sterilization

[00852897002083]

Moist Heat or Steam Sterilization

[00852897002083]

Moist Heat or Steam Sterilization

[00852897002083]

Moist Heat or Steam Sterilization

[00852897002083]

Moist Heat or Steam Sterilization

[00852897002083]

Moist Heat or Steam Sterilization

[00852897002083]

Moist Heat or Steam Sterilization

[00852897002083]

Moist Heat or Steam Sterilization

[00852897002083]

Moist Heat or Steam Sterilization

[00852897002083]

Moist Heat or Steam Sterilization

[00852897002083]

Moist Heat or Steam Sterilization

[00852897002083]

Moist Heat or Steam Sterilization

[00852897002083]

Moist Heat or Steam Sterilization

[00852897002083]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-13

On-Brand Devices [Cartiva SCI Placer]

00852897002151Surgical Instrument- 10 mm Placer
00852897002144Surgical Instrument- 8 mm Placer
00852897002090Surgical Instrument- 10 mm Placer
00852897002083Surgical Instrument- 8 mm Placer
00852897002991Surgical Instrument- 6 mm Placer
00852897002960Surgical Instrument- 12 mm Placer
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