HYPE stem

GUDID 03662200019632

SOC ETUDES RECHERCHES FABRICATION

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID03662200019632
NIH Device Record Key980f29d1-bcf1-4daf-9d99-1b07768b41d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameHYPE stem
Version Model NumberTE607- 32 CC
Company DUNS282651413
Company NameSOC ETUDES RECHERCHES FABRICATION
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 Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103662200019632 [Primary]

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03662200019632]

Moist Heat or Steam Sterilization


[03662200019632]

Moist Heat or Steam Sterilization


[03662200019632]

Moist Heat or Steam Sterilization


[03662200019632]

Moist Heat or Steam Sterilization


[03662200019632]

Moist Heat or Steam Sterilization


[03662200019632]

Moist Heat or Steam Sterilization


[03662200019632]

Moist Heat or Steam Sterilization


[03662200019632]

Moist Heat or Steam Sterilization


[03662200019632]

Moist Heat or Steam Sterilization


[03662200019632]

Moist Heat or Steam Sterilization


[03662200019632]

Moist Heat or Steam Sterilization


[03662200019632]

Moist Heat or Steam Sterilization


[03662200019632]

Moist Heat or Steam Sterilization


[03662200019632]

Moist Heat or Steam Sterilization


[03662200019632]

Moist Heat or Steam Sterilization


[03662200019632]

Moist Heat or Steam Sterilization


[03662200019632]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-26
Device Publish Date2024-02-16

On-Brand Devices [HYPE stem]

03662200017676COE634B
03662200017669COE633LATP
03662200017652COE632LATI
03662200017645COE631STP
03662200017638COE630STI
03662200017621COE SCV
03662200017027COE SCL
03662200017010COE SCS
03662200016723AR700
03662200019700OST600
03662200019441RH605 U11
03662200019434RH605 U10
03662200019427RH605 U9
03662200019410RH605 U8
03662200019403RH605 U7
03662200019397RH605 U6
03662200019380RH605 U5
03662200019373RH605 U4
03662200019366RH605 U3
03662200019359RH605 U2
03662200019342RH605 U1
03662200018970PIC601
03662200018963PI600
03662200018925PPI600
03662200018895OR601
03662200018888OR600
03662200018826MI605
03662200018659IP605
03662200018642IPC604
03662200018345FC603 ADAPTATEUR
03662200018338FC603
03662200018086ET602
03662200017966EI602
03662200017942COEH 11
03662200017935COEH 10
03662200017928COEH 9
03662200017911COEH 8
03662200017904COEH 7
03662200017898COEH 6
03662200017881COEH 5
03662200017874COEH 4
03662200017867COEH 3
03662200017850COEH 2
03662200017843COEH 1
03662200017836COEH LAT
03662200017829COEH STD
03662200017195MR606G
03662200017188MR606D
03662200017171MR605
03662200017058MR604

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.