FDA.reportPublic FDA data

Silicone MCP

Primary DI
00885556856918
Brand
Silicone MCP
Company
Smith & Nephew, Inc.
Model
SMCP-500-40-WW
Catalog number
SMCP-500-40-WW
Device description
Silicone MCP Sz 40
Published
2022-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KYJProsthesis, finger, constrained, polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYJProsthesis, Finger, Constrained, PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022892000
K233670000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022892000ASCENSION SILLICONE MCPAscension Orthopedics, Inc.2002-11-25KYJ
K233670000Ascension Silicone MCP; Ascension Silicone PIPAscension Orthopedics, Inc.2023-12-14KYJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556856918PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556856918008855568569188855568569180885556856918

GMDN Terms#

Term, Definition table
TermDefinition
Metacarpophalangeal joint prosthesis, one-pieceAn implantable artificial substitute for the metacarpophalangeal (MCP) joint(s) of the hand (finger) which has been damaged by rheumatoid, degenerative, or traumatic arthritis. It consists of a single flexible across-the-joint component (one-piece) made from either a silicone elastomer or a combination of polypropylene and polyester materials. The flexible across-the-joint component may be covered with a silicone rubber sleeve.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010194534SYNERGY71306709713067092015-08-30
03596010194541SYNERGY71306710713067102015-08-30
03596010194558SYNERGY71306711713067112015-08-30
03596010194565SYNERGY71306712713067122015-08-30
03596010194572SYNERGY71306713713067132015-08-30
03596010194589SYNERGY71306714713067142015-08-30
03596010194596SYNERGY71306715713067152015-08-30
03596010194602SYNERGY71306716713067162015-08-30
03596010194619SYNERGY71306717713067172015-08-30
03596010194626SYNERGY71306718713067182015-08-30
03596010384935SYNERGY71306409713064092015-08-29
03596010384942SYNERGY71306410713064102015-08-29
03596010384966SYNERGY71306411713064112015-08-29
03596010384973SYNERGY71306412713064122015-08-29
03596010384980SYNERGY71306413713064132015-08-30
03596010384997SYNERGY71306414713064142015-08-30
03596010385000SYNERGY71306415713064152015-08-30
03596010385017SYNERGY71306416713064162015-08-30
03596010385024SYNERGY71306417713064172015-08-30
03596010385031SYNERGY71306418713064182015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057717554519DIGITALIS SpacerBRM EXTREMITIES SRLKYJ2024-05-13
08057717554526DIGITALIS SpacerBRM EXTREMITIES SRLKYJ2024-05-13
08057717554533DIGITALIS SpacerBRM EXTREMITIES SRLKYJ2024-05-13
08057717554540DIGITALIS SpacerBRM EXTREMITIES SRLKYJ2024-05-13
08057717554557DIGITALIS SpacerBRM EXTREMITIES SRLKYJ2024-05-13
08057717554564DIGITALIS SpacerBRM EXTREMITIES SRLKYJ2024-05-13
08057717554571DIGITALIS SpacerBRM EXTREMITIES SRLKYJ2024-05-13
08057717554588DIGITALIS SpacerBRM EXTREMITIES SRLKYJ2024-05-13
08057717554595DIGITALIS SpacerBRM EXTREMITIES SRLKYJ2024-05-13
00885556856871Silicone MCPSmith & Nephew, Inc.KYJ2022-12-22
00885556856888Silicone MCPSmith & Nephew, Inc.KYJ2022-12-22
00885556856895Silicone MCPSmith & Nephew, Inc.KYJ2022-12-22
00885556856901Silicone MCPSmith & Nephew, Inc.KYJ2022-12-22
00885556856925Silicone MCPSmith & Nephew, Inc.KYJ2022-12-22
00885556856963Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556856970Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556856987Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556856994Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556857007Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556857014Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556857021Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556857038Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556857045Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556857052Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556857069Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556857076Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556857083Silicone MCPSmith & Nephew, Inc.KYJ2022-12-22
00885556857090Silicone MCPSmith & Nephew, Inc.KYJ2022-12-22
00885556857106Silicone MCPSmith & Nephew, Inc.KYJ2022-12-22
00885556857113Silicone MCPSmith & Nephew, Inc.KYJ2022-12-22