Touch CMC 1 - Straight Neck Pattern 10-L

GUDID 07640181160822

Keri Medical SA

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID07640181160822
NIH Device Record Key0f4c1aa8-ec57-48fc-8f5e-6cab69300db0
Commercial Distribution StatusIn Commercial Distribution
Brand NameTouch CMC 1 - Straight Neck Pattern 10-L
Version Model Number112-A50010
Company DUNS480138827
Company NameKeri Medical SA
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107640181160822 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

SFAProsthesis, Finger, Semi-Constrained, Metal/Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07640181160822]

Moist Heat or Steam Sterilization


[07640181160822]

Moist Heat or Steam Sterilization


[07640181160822]

Moist Heat or Steam Sterilization


[07640181160822]

Moist Heat or Steam Sterilization


[07640181160822]

Moist Heat or Steam Sterilization


[07640181160822]

Moist Heat or Steam Sterilization


[07640181160822]

Moist Heat or Steam Sterilization


[07640181160822]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-29
Device Publish Date2025-07-21

Devices Manufactured by Keri Medical SA

07640181160808 - Touch CMC 1 - Straight Neck Pattern 6-S2025-07-29
07640181160815 - Touch CMC 1 - Straight Neck Pattern 8-M2025-07-29
07640181160822 - Touch CMC 1 - Straight Neck Pattern 10-L2025-07-29
07640181160822 - Touch CMC 1 - Straight Neck Pattern 10-L2025-07-29
07640181160839 - Touch CMC 1 - Offset Neck Pattern 6-S2025-07-29
07640181160846 - Touch CMC 1 - Offset Neck Pattern 8-M2025-07-29
07640181160853 - Touch CMC 1 - Offset Neck Pattern 10-L2025-07-29
07640181160860 - Touch CMC 1 - Spherical Cup Pattern Ø92025-07-29
07640181160877 - Touch CMC 1 - Spherical Cup Pattern Ø102025-07-29

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