FDA.reportPublic FDA data

Stem holder

Primary DI
07640181160914
Brand
Stem holder
Company
Keri Medical SA
Model
112-A32000
Published
2025-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
SFAProsthesis, Finger, Semi-Constrained, Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SFAProsthesis, Finger, Semi-Constrained, Metal/PolymerUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P240020000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P240020000TOUCH® CMC 1 ProsthesisKeri Medical SA2025-07-10SFA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640181160914PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640181160914076401811609147640181160914

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
480138827
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640181162833Kirschner wire Tube 16 cm Ø12mm000-A005002025-07-21
07640181163106Kirschner wire (Ø1.2 x 80 mm)000-A006502025-07-21
07640181160808Straight Neck Pattern 6-S112-A500062025-07-21
07640181160815Straight Neck Pattern 8-M112-A500082025-07-21
07640181160822Straight Neck Pattern 10-L112-A500102025-07-21
07640181160839Offset Neck Pattern 6-S112-A515062025-07-21
07640181160846Offset Neck Pattern 8-M112-A515082025-07-21
07640181160853Offset Neck Pattern 10-L112-A515102025-07-21
07640181160860Spherical Cup Pattern Ø9112-A200002025-07-21
07640181160877Spherical Cup Pattern Ø10112-A200102025-07-21
07640181160884Conical Cup Pattern Ø9112-A201002025-07-21
07640181160891Conical Cup Pattern Ø10112-A201102025-07-21
07640181160921K-Wire Centering Guide112-A280002025-07-21
07640181161003Stem Pattern 0112-A301002025-07-21
07640181161010Stem Pattern 1112-A301012025-07-21
07640181161027Stem Pattern 2112-A301022025-07-21
07640181161034Stem Pattern 3112-A301032025-07-21
07640181161041Stem Pattern 4112-A301042025-07-21
07640181161058Stem Pattern XS112-A301052025-07-21
07640181161256Forked retractor112-A002002026-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640181161256Forked retractorKeri Medical SASFA2026-03-09
07640181160945Metacarpal rasp 0Keri Medical SASFA2025-07-21
07640181160952Metacarpal rasp 1Keri Medical SASFA2025-07-21
07640181160969Metacarpal rasp 2Keri Medical SASFA2025-07-21
07640181160976Metacarpal rasp 3Keri Medical SASFA2025-07-21
07640181160983Metacarpal rasp 4Keri Medical SASFA2025-07-21
07640181160990Metacarpal rasp XSKeri Medical SASFA2025-07-21
07640181160808Straight Neck Pattern 6-SKeri Medical SASFA2025-07-21
07640181160815Straight Neck Pattern 8-MKeri Medical SASFA2025-07-21
07640181160822Straight Neck Pattern 10-LKeri Medical SASFA2025-07-21
07640181160839Offset Neck Pattern 6-SKeri Medical SASFA2025-07-21
07640181160846Offset Neck Pattern 8-MKeri Medical SASFA2025-07-21
07640181160853Offset Neck Pattern 10-LKeri Medical SASFA2025-07-21
07640181160860Spherical Cup Pattern Ø9Keri Medical SASFA2025-07-21
07640181160877Spherical Cup Pattern Ø10Keri Medical SASFA2025-07-21
07640181160884Conical Cup Pattern Ø9Keri Medical SASFA2025-07-21
07640181160891Conical Cup Pattern Ø10Keri Medical SASFA2025-07-21
07640181160921K-Wire Centering GuideKeri Medical SASFA2025-07-21
07640181161003Stem Pattern 0Keri Medical SASFA2025-07-21
07640181161010Stem Pattern 1Keri Medical SASFA2025-07-21
07640181161027Stem Pattern 2Keri Medical SASFA2025-07-21
07640181161034Stem Pattern 3Keri Medical SASFA2025-07-21
07640181161041Stem Pattern 4Keri Medical SASFA2025-07-21
07640181161058Stem Pattern XSKeri Medical SASFA2025-07-21
07640181161188Cannulated Spherical Reamer Ø9 mmKeri Medical SASFA2025-07-21
07640181161195Cannulated Spherical Reamer Ø10 mmKeri Medical SASFA2025-07-21
07640181161201Cannulated Conical Reamer Ø9 mmKeri Medical SASFA2025-07-21
07640181161218Cannulated Conical Reamer Ø10 mmKeri Medical SASFA2025-07-21
07640181161232Cannulated trapezium starterKeri Medical SASFA2025-07-21
07640181161249Neck holding forcepsKeri Medical SASFA2025-07-21