FDA.reportPublic FDA data

Metacarpal rasp 3

Primary DI
07640181160976
Brand
Metacarpal rasp 3
Company
Keri Medical SA
Model
112-A31003
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
07640181160976PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640181160976076401811609767640181160976

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
07640181161270Straight AO Handle112-A910002025-07-21
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

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
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
07640181160914Stem holderKeri 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