FDA.reportPublic FDA data

SR PIP

Primary DI
00886385019741
Brand
SR PIP
Company
Stryker GmbH
Model
17-1315
Device description
SIZE 1: PIP PROXIMAL 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
00886385019741PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886385019741008863850197418863850197410886385019741

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
00886385017365STAR908-0110-02908-0110-022022-02-14
00886385018836STAR933-0003-02933-0003-022022-02-14
00886385018843STAR933-0003-03933-0003-032022-02-14
00886385019055STAR933-0025-02933-0025-022022-02-14
00886385019062STAR933-0025-03933-0025-032022-02-14
00886385019147STAR933-0029-02933-0029-022022-02-14
00886385017150STAR905-0066905-00662020-09-24
07613327350296NA2351-00202351-00202018-11-02
07613327361650NA2351-01402351-01402018-11-02
07613327361667NA2351-03402351-03402018-11-02
07613327361674NA2351-00302351-00302018-11-02
07613327361681NA2351-00602351-00602018-11-02
07613327361780NA2351-42902351-42902018-11-02
07613327368154NA2351-00702351-00702018-11-02
07613327368178NA2351-42802351-42802018-11-02
07613327376197NA2351-04202351-04202018-11-01
07613327376203NA2351-03802351-03802018-11-01
00886385016412STAR™400-2502017-06-27
00886385016429STAR™400-2512017-06-27
00886385016436STAR™400-2522017-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00886385020303SR PIPStryker GmbHMPK2017-06-27