Osteotec Silicone Finger Implant - Size 9 OSTF-9

GUDID 05060183090101

The Osteotec Silicone Finger Implant is a one-piece, flexible silicone elastomer implant which is placed in the proximal and distal intramedullary canals of either metacarpophalangeal (MCP) or proximal interphalangeal (PIP) finger joints during resection arthroplasty.

OSTEOTEC LIMITED

Metacarpophalangeal/proximal interphalangeal joint prosthesis
Primary Device ID05060183090101
NIH Device Record Key15e437e8-eeab-411c-8bfa-de2c81dfd0a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsteotec Silicone Finger Implant - Size 9
Version Model NumberOSTF-9
Catalog NumberOSTF-9
Company DUNS348489386
Company NameOSTEOTEC LIMITED
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105060183090101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KYJProsthesis, Finger, Constrained, Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-14
Device Publish Date2022-02-04

Devices Manufactured by OSTEOTEC LIMITED

05060183095588 - Osteotec Silicone Finger - Osteotec All In One Silicone Finger Set2024-01-11 Tray of Osteotec Silicone Finger Sizers and Instruments
05060079820355 - Chiroklip wire protector 2 pack blister2022-02-14 ChiroKlip is a small butterfly shaped aluminium clip with an adhesive foam covering. It is designed to fold around the end of a
05060183090002 - Osteotec Silicone Finger Implant - Size 002022-02-14 The Osteotec Silicone Finger Implant is a one-piece, flexible silicone elastomer implant which is placed in the proximal and dis
05060183090019 - Osteotec Silicone Finger Implant - Size 02022-02-14 The Osteotec Silicone Finger Implant is a one-piece, flexible silicone elastomer implant which is placed in the proximal and dis
05060183090026 - Osteotec Silicone Finger Implant - Size 12022-02-14 The Osteotec Silicone Finger Implant is a one-piece, flexible silicone elastomer implant which is placed in the proximal and dis
05060183090033 - Osteotec Silicone Finger Implant - Size 22022-02-14 The Osteotec Silicone Finger Implant is a one-piece, flexible silicone elastomer implant which is placed in the proximal and dis
05060183090040 - Osteotec Silicone Finger Implant - Size 32022-02-14 The Osteotec Silicone Finger Implant is a one-piece, flexible silicone elastomer implant which is placed in the proximal and dis
05060183090057 - Osteotec Silicone Finger Implant - Size 42022-02-14 The Osteotec Silicone Finger Implant is a one-piece, flexible silicone elastomer implant which is placed in the proximal and dis

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