FDA.reportPublic FDA data

SR MCP

Primary DI
00886385020846
Brand
SR MCP
Company
Stryker GmbH
Model
17-1514
Device description
S.R. MCP PHALANGEAL TRIAL, SIZE XL
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

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
00886385020846PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886385020846008863850208468863850208460886385020846

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
481999654
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
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