FDA.reportPublic FDA data

SR PIP

Primary DI
00886385020334
Brand
SR PIP
Company
Stryker GmbH
Model
SR PIP-3
Device description
Proximal Interphalangeal Implant, Size 3
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
00886385020334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886385020334008863850203348863850203340886385020334

GMDN Terms#

Term, Definition table
TermDefinition
Proximal interphalangeal joint prosthesis, modularA sterile, implantable artificial substitute for the proximal interphalangeal (PIP) joint(s) of the hand (finger) which typically has been damaged by rheumatoid, degenerative, or traumatic arthritis. The device typically consists of proximal and distal metal (e.g., titanium) stems, which may be coated with a material (e.g., hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth, for insertion into the prepared phalanges of the joint. The stems may have articulating surfaces or there may be separate metal [e.g., cobalt-chrome (Co-Cr)] and/or plastic ( e.g., polyethylene) articulating surface components. Dedicated tools for implantation may be included.

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
07613327625066PANGEA5421165421162024-12-01
00886385019741SR PIP17-13152017-06-27
00886385019758SR PIP17-13162017-06-27
00886385019765SR PIP17-13172017-06-27
00886385019772SR PIP17-13182017-06-27
00886385019789SR PIP17-13192017-06-27
00886385019796SR PIP17-13202017-06-27
00886385019802SR PIP17-13212017-06-27
00886385019819SR PIP17-13222017-06-27
00886385019826SR PIP17-13232017-06-27
00886385019833SR PIP17-13242017-06-27
00886385019840SR PIP17-13252017-06-27
00886385019857SR PIP17-13262017-06-27
00886385019864SR PIP17-13272017-06-27
00886385019871SR PIP17-13282017-06-27
00886385019888SR PIP17-13292017-06-27
00886385019895SR PIP17-13302017-06-27
00886385019901SR PIP17-13312017-06-27
00886385019918SR PIP17-13322017-06-27
00886385019925SR PIP17-13332017-06-27

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