FDA.reportPublic FDA data

SR PIP

Primary DI
00886385019802
Brand
SR PIP
Company
Stryker GmbH
Model
17-1321
Device description
SIZE 2: PIP DISTAL TRIAL
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
00886385019802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886385019802008863850198028863850198020886385019802

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
07613327414127PANGEA706408S706408S2023-06-13
07613327415582PANGEA706407S706407S2023-06-13
07613327416138PANGEA706406S706406S2023-06-13
07613327539585PANGEA706444S706444S2023-06-13
07613327541731PANGEA703551S703551S2023-06-13
07613327541748PANGEA703555S703555S2023-06-13
07613154969357VARIAX45-35015S45-35015S2020-09-24
04546540195913NA1806-0083S1806-0083S2020-04-07
04546540195937NA1806-0085S1806-0085S2020-04-07
04546540195951NA1806-0090S1806-0090S2020-04-07
04546540195975NA1806-0093S1806-0093S2020-04-07
07613154633326NA45-20011S45-20011S2018-09-24
07613154633432NA45-30011S45-30011S2018-09-24
07613154665891NA45-20001S45-20001S2018-09-24
07613154665907NA45-20004S45-20004S2018-09-24
07613154665914NA45-30001S45-30001S2018-09-24
07613154665921NA45-30004S45-30004S2018-09-24
07613327083286AXSOS705077S705077S2016-09-24
07613327083323AXSOS705078S705078S2016-09-24
07613327083330AXSOS705031S705031S2016-09-24

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
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
00886385020303SR PIPStryker GmbHMPK2017-06-27