FDA.reportPublic FDA data

Ascension MCP Joint Replacement

Primary DI
00885556856796
Brand
Ascension MCP Joint Replacement
Company
Smith & Nephew, Inc.
Model
MCP-100-50D-WW
Catalog number
MCP-100-50D-WW
Device description
MCP SZ. 50 DISTAL WW
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
NEGFinger semi-constrained pyrolytic carbon uncemented prosthesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEGFinger Semi-Constrained Pyrolytic Carbon Uncemented ProsthesisUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P000057007

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P000057007ASCENSION MCPSmith & Nephew, Inc.2001-11-19NEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556856796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556856796008855568567968855568567960885556856796

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.

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
00885554009101NA720770572077052015-08-30
00885556925690NAROB30080ROB300802026-06-04
03596010589101JOURNEY71422274714222742015-08-30
03596010589132JOURNEY71422277714222772015-08-30
03596010000675OXINIUM71343603713436032015-08-30
03596010474148OXINIUM71342800713428002015-08-30
03596010474162OXINIUM71342804713428042015-08-30
03596010474179OXINIUM71342808713428082015-08-30
03596010474209OXINIUM71343200713432002015-08-30
03596010474216OXINIUM71343203713432032015-08-30
03596010474223OXINIUM71343204713432042015-08-30
03596010474230OXINIUM71343208713432082015-08-30
03596010477279OXINIUM71343600713436002015-08-30
03596010477286OXINIUM71343604713436042015-08-30
03596010477293OXINIUM71343608713436082015-08-30
03596010488862OXINIUM71342200713422002015-08-30
03596010544193JOURNEY71461012714610122015-08-30
03596010544209JOURNEY71461013714610132015-08-30
03596010544216JOURNEY71461014714610142015-08-30
03596010544223JOURNEY71461015714610152015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556856710Ascension MCP Joint ReplacementSmith & Nephew, Inc.NEG2022-12-22
00885556856734Ascension MCP Joint ReplacementSmith & Nephew, Inc.NEG2022-12-22
00885556856758Ascension MCP Joint ReplacementSmith & Nephew, Inc.NEG2022-12-22
00885556856772Ascension MCP Joint ReplacementSmith & Nephew, Inc.NEG2022-12-22
00885556856819Ascension MCP Joint ReplacementSmith & Nephew, Inc.NEG2022-12-22
00885556856727Ascension MCP Joint ReplacementSmith & Nephew, Inc.NEG2022-12-22
00885556856741Ascension MCP Joint ReplacementSmith & Nephew, Inc.NEG2022-12-22
00885556856765Ascension MCP Joint ReplacementSmith & Nephew, Inc.NEG2022-12-22
00885556856789Ascension MCP Joint ReplacementSmith & Nephew, Inc.NEG2022-12-22
00885556856802Ascension MCP Joint ReplacementSmith & Nephew, Inc.NEG2022-12-22
00885556856826Ascension MCP Joint ReplacementSmith & Nephew, Inc.NEG2022-12-22
10381780000341Ascension® MCPAscension Orthopedics, Inc.NEG2014-09-18
10381780000358Ascension® MCPAscension Orthopedics, Inc.NEG2014-09-18
10381780000365Ascension® MCPAscension Orthopedics, Inc.NEG2014-09-18
10381780000372Ascension® MCPAscension Orthopedics, Inc.NEG2014-09-18
10381780000389Ascension® MCPAscension Orthopedics, Inc.NEG2014-09-18
10381780000396Ascension® MCPAscension Orthopedics, Inc.NEG2014-09-18
10381780000402Ascension® MCPAscension Orthopedics, Inc.NEG2014-09-18
10381780000419Ascension® MCPAscension Orthopedics, Inc.NEG2014-09-18
10381780000426Ascension® MCPAscension Orthopedics, Inc.NEG2014-09-18
10381780000433Ascension® MCPAscension Orthopedics, Inc.NEG2014-09-18
10381780000440Ascension® MCPAscension Orthopedics, Inc.NEG2014-09-18
10381780000457Ascension® MCPAscension Orthopedics, Inc.NEG2014-09-18
M269MCP11005DWW1Ascension MCPAscension Orthopedics, Inc.NEG2014-09-18
M269MCP11005PWW1Ascension MCPAscension Orthopedics, Inc.NEG2014-09-18
M269MCP10010DWW1Ascension MCPAscension Orthopedics, Inc.NEG2014-09-18
M269MCP10010PWW1Ascension MCPAscension Orthopedics, Inc.NEG2014-09-18
M269MCP10020DWW1Ascension MCPAscension Orthopedics, Inc.NEG2014-09-18
M269MCP10020PWW1Ascension MCPAscension Orthopedics, Inc.NEG2014-09-18
M269MCP10030DWW1Ascension MCPAscension Orthopedics, Inc.NEG2014-09-18