FDA.report

SR™ PIP

Primary DI
00886385019802
Brand
SR™ PIP
Company
Stryker Trauma SA
Model
17-1321
Device description
SIZE 2: PIP DISTAL TRIAL
Published
2017-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MPKSemi-Constrained Metal/Polymer Finger Joint Prosthesis

Product Code Classifications

CodeDeviceSpecialtyClass
MPKSemi-Constrained Metal/Polymer Finger Joint ProsthesisUnknownf

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00886385019802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00886385019802008863850198028863850198020886385019802

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1-201-831-5000xx@xx.xx

Regulatory Flags

DUNS number
481999654
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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07613327624991PANGEA5421205421202024-12-01
07613327625011PANGEA542132S542132S2024-12-01
07613327625028PANGEA5421135421132024-12-01
07613327625035PANGEA5421865421862024-12-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00886385019741SR™ PIPStryker Trauma SAMPK2017-06-27
00886385019758SR™ PIPStryker Trauma SAMPK2017-06-27
00886385019765SR™ PIPStryker Trauma SAMPK2017-06-27
00886385019772SR™ PIPStryker Trauma SAMPK2017-06-27
00886385019789SR™ PIPStryker Trauma SAMPK2017-06-27
00886385019796SR™ PIPStryker Trauma SAMPK2017-06-27
00886385019819SR™ PIPStryker Trauma SAMPK2017-06-27
00886385019826SR™ PIPStryker Trauma SAMPK2017-06-27
00886385019833SR™ PIPStryker Trauma SAMPK2017-06-27
00886385019840SR™ PIPStryker Trauma SAMPK2017-06-27
00886385019857SR™ PIPStryker Trauma SAMPK2017-06-27
00886385019864SR™ PIPStryker Trauma SAMPK2017-06-27
00886385019871SR™ PIPStryker Trauma SAMPK2017-06-27
00886385019888SR™ PIPStryker Trauma SAMPK2017-06-27
00886385019895SR™ PIPStryker Trauma SAMPK2017-06-27
00886385019901SR™ PIPStryker Trauma SAMPK2017-06-27
00886385019918SR™ PIPStryker Trauma SAMPK2017-06-27
00886385019925SR™ PIPStryker Trauma SAMPK2017-06-27
00886385019932SR™ PIPStryker Trauma SAMPK2017-06-27
00886385020044SR™ PIPStryker Trauma SAMPK2017-06-27
00886385020068SR™ PIPStryker Trauma SAMPK2017-06-27
00886385020075SR™ PIPStryker Trauma SAMPK2017-06-27
00886385020105SR™ PIPStryker Trauma SAMPK2017-06-27
00886385020112SR™ PIPStryker Trauma SAMPK2017-06-27
00886385020129SR™ PIPStryker Trauma SAMPK2017-06-27
00886385020266SR™ PIPStryker Trauma SAMPK2017-06-27
00886385020273SR™ PIPStryker Trauma SAMPK2017-06-27
00886385020280SR™ PIPStryker Trauma SAMPK2017-06-27
00886385020297SR™ PIPStryker Trauma SAMPK2017-06-27
00886385020303SR™ PIPStryker Trauma SAMPK2017-06-27