TEHLIN

GUDID 04719883460264

"CHILD'S HY-STAN HIP JOINT / RED"

TEH LIN PROSTHETIC & ORTHOPAEDIC INC.

Mechanical-resistance external knee prosthesis Mechanical-resistance external knee prosthesis Mechanical-resistance external knee prosthesis Mechanical-resistance external knee prosthesis Mechanical-resistance external knee prosthesis Mechanical-resistance external knee prosthesis Mechanical-resistance external knee prosthesis Mechanical-resistance external knee prosthesis Mechanical-resistance external knee prosthesis Mechanical-resistance external knee prosthesis Mechanical-resistance external knee prosthesis Mechanical-resistance external knee prosthesis Mechanical-resistance external knee prosthesis
Primary Device ID04719883460264
NIH Device Record Keye23c06da-2bb6-42ce-ad8e-6f7b936ea1e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameTEHLIN
Version Model NumberC-TCH-01R
Company DUNS657485074
Company NameTEH LIN PROSTHETIC & ORTHOPAEDIC INC.
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 Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104719883460264 [Primary]

FDA Product Code

ISYJoint, Knee, External Limb Component

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-08
Device Publish Date2023-10-31

On-Brand Devices [TEHLIN]

04719883462909AK WEDGE PLATE (ALUMINUM)
04719883462763BK WIRE SOCKET CONNECTOR WITH NUT
04719883462756CHILD'S AK WIRE SOCKET CONNECTOR WITH NUT
04719883462749PAD-PAS SOCKET CONNECTOR STEEL
047198834627324-SCREW BK WIRE SOCKET CONNECTOR
04719883462718AK WIRE SOCKET CONNECTOR WITH NUT
04719883462688MINI 4 BAR CHILD'S PNEUMATIC KNEE
04719883462664CHILD'S SOCKET ADAPTER & MALE PYRAMID W. 3/8" CENTRAL BOLT
04719883462657LOCKING HANDLE WITH CABLE FOR TGK-4001/TK-4001S/TGK-4002/TK-4002
04719883462602CHILD'S ANGLED CONNECTOR
0471988346258914" CARBON FIBER TUBE
04719883462398CHILD'S EVA-LAST COSMETIC COVER, EXTRA SMALL / RIGHT
04719883462381CHILD'S EVA-LAST COSMETIC COVER, EXTRA SMALL / LEFT
04719883462374EVA-LAST COSMETIC COVER, SMALL / RIGHT
04719883462367EVA-LAST COSMETIC COVER, SMALL / LEFT
04719883462350EVA-LAST COSMETIC COVER, MEDIUM / RIGHT
04719883462343EVA-LAST COSMETIC COVER, LARGE / RIGHT
04719883460912BK EXOSKELETAL FOAM COVER
0471988346074515" CHILD'S TUBE
04719883460714CHILD'S L-BRACKET, STEEL WITH EXTENSIONS
04719883460660BK EXOSKELETAL FOAM COVER
04719883460622LAMINATION PLATE (ALUMINUM)
04719883460608KNEE ROTATOR
04719883460554EVA-LAST COSMETIC COVER, LARGE / LEFT
04719883460523L-BRACKET, STEEL WITH EXTENSIONS
04719883460332HY-STAN CHILD'S 4 BAR KNEE
04719883460325HY-STAN 4 BAR KNEE DISARTICULATION KNEE
04719883460318HY-STAN 4 BAR KNEE WITH 30° MANUAL LOCK
04719883460301HY-STAN 4 BAR KNEE WITH MANUAL LOCK
04719883460288HY-STAN SINGLE AXIS CHILD'S KNEE WITH MANUAL LOCK
04719883460271HY-STAN HIP JOINT
04719883460264"CHILD'S HY-STAN HIP JOINT / RED"
04719883460165EVA-LAST COSMETIC COVER, MEDIUM / LEFT
04719883460158GRAPH-LITE 5 BAR KNEE
04719883460110GRAPH-LITE 5 BAR PNEUMATIC KNEE HIGH ACTIVITY
04719883460103GRAPH-LITE 5 BAR PNEUMATIC KNEE - DISARTICULATION KNEE
04719883460073GRAPH-LITE 4 BAR PNEUMATIC KNEE - DISARTICULATION KNEE
04719883460066GRAPH-LITE 4 BAR PNEUMATIC KNEE (MINI)
04719883460059PHOENIX GRAPH-LITE 4 BAR PNEUMATIC KNEE
04719883460035GRAPH-LITE 4 BAR KNEE WITH 30° MANUAL LOCK
04719883460028GRAPH-LITE 4 BAR KNEE WITH MANUAL LOCK
04719883460004GRAPH-LITE HIP JOINT
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.