FDA.reportPublic FDA data

SR MCP

Primary DI
00886385021010
Brand
SR MCP
Company
Stryker GmbH
Model
5800-MD00
Device description
SR MCP, IMPLANT, SIZE MEDIUM
Published
2017-06-27
Public version status
Update
Distribution status
Not 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
MPKSemi-Constrained Metal/Polymer Finger Joint Prosthesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MPKSemi-Constrained Metal/Polymer Finger Joint ProsthesisUnknownf

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886385021010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886385021010008863850210108863850210100886385021010

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid exposure to direct sunlight or dampness

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-201-831-5000xx@xx.xx

Regulatory Flags#

DUNS number
481999654
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327172645ASNIS7053557053552016-07-25
07613327172652ASNIS705355S705355S2016-07-25
07613327172690ASNIS7053607053602016-07-25
07613327172706ASNIS7053637053632016-07-25
07613327172720ASNIS7053627053622016-07-25
07613327172737ASNIS7053657053652016-07-25
07613327172751ASNIS7053647053642016-07-25
07613327172768ASNIS7053617053612016-07-25
07613327172775ASNIS7053697053692016-07-25
07613327172812ASNIS7053717053712016-07-25
07613327172843ASNIS7053707053702016-07-25
07613327172867ASNIS7053667053662016-07-25
04546540112859NA7026227026222020-09-24
04546540112927NA7026297026292020-09-24
04546540145321BIXCUT0225-60750225-60752020-04-07
04546540145338BIXCUT0225-60800225-60802020-04-07
04546540145369BIXCUT0225-60950225-60952020-04-07
04546540145376BIXCUT0225-61000225-61002020-04-07
04546540145390BIXCUT0225-61100225-61102020-04-07
04546540145413BIXCUT0225-81150225-81152020-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00886385019741SR PIPStryker GmbHMPK2017-06-27
00886385019758SR PIPStryker GmbHMPK2017-06-27
00886385019765SR PIPStryker GmbHMPK2017-06-27
00886385019772SR PIPStryker GmbHMPK2017-06-27
00886385019789SR PIPStryker GmbHMPK2017-06-27
00886385019796SR PIPStryker GmbHMPK2017-06-27
00886385019802SR PIPStryker GmbHMPK2017-06-27
00886385019819SR PIPStryker GmbHMPK2017-06-27
00886385019826SR PIPStryker GmbHMPK2017-06-27
00886385019833SR PIPStryker GmbHMPK2017-06-27
00886385019840SR PIPStryker GmbHMPK2017-06-27
00886385019857SR PIPStryker GmbHMPK2017-06-27
00886385019864SR PIPStryker GmbHMPK2017-06-27
00886385019871SR PIPStryker GmbHMPK2017-06-27
00886385019888SR PIPStryker GmbHMPK2017-06-27
00886385019895SR PIPStryker GmbHMPK2017-06-27
00886385019901SR PIPStryker GmbHMPK2017-06-27
00886385019918SR PIPStryker GmbHMPK2017-06-27
00886385019925SR PIPStryker GmbHMPK2017-06-27
00886385019932SR PIPStryker GmbHMPK2017-06-27
00886385020044SR PIPStryker GmbHMPK2017-06-27
00886385020068SR PIPStryker GmbHMPK2017-06-27
00886385020075SR PIPStryker GmbHMPK2017-06-27
00886385020105SR PIPStryker GmbHMPK2017-06-27
00886385020112SR PIPStryker GmbHMPK2017-06-27
00886385020129SR PIPStryker GmbHMPK2017-06-27
00886385020266SR PIPStryker GmbHMPK2017-06-27
00886385020273SR PIPStryker GmbHMPK2017-06-27
00886385020280SR PIPStryker GmbHMPK2017-06-27
00886385020297SR PIPStryker GmbHMPK2017-06-27