FDA.reportPublic FDA data

BioPrep

Primary DI
04546540039637
Brand
BioPrep
Company
STRYKER CORPORATION
Model
0206710000
Catalog number
0206-710-000
Device description
Bone Preparation Kit
Published
2015-09-23
Public version status
Update
Distribution status
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
JDKProsthesis, hip, cement restrictor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDKProsthesis, Hip, Cement RestrictorGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34546540039638PackageGS16In Commercial Distribution
04546540039637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3454654003963834546540039638
04546540039637045465400396374546540039637

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement, non-antimicrobialA substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. It may also be intended for use as a filler in the case of bone pathologies (e.g., to stabilize and reinforce vertebral body structures in vertebroplasty and kyphoplasty). It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene. This device does not contain an antimicrobial agent. After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
+1(800)253-3210Inst.Stryker.cs@Stryker.com

Regulatory Flags#

DUNS number
196548481
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04546540434364SpinePlex04062020000406-202-0002016-06-30
07613154599097NA59200002015920-000-2012016-09-23
07613154599103NA59200002025920-000-2022018-09-24
07613154599110NA59200002035920-000-2032018-09-24
07613154599134NA59200002055920-000-2052018-09-24
07613154599141NA59200002065920-000-2062018-09-24
07613154599158NA59200002075920-000-2072018-09-24
07613154599165NA59200002085920-000-2082018-09-24
07613154599172NA59200002095920-000-2092018-09-24
07613154599189NA59200003015920-000-3012018-09-24
07613154599196NA59200003025920-000-3022018-09-24
07613154599202NA59200003035920-000-3032018-09-24
07613154599219NA59200003045920-000-3042018-09-24
07613154599226NA59200003055920-000-3052018-09-24
07613154599233NA59200003065920-000-3062018-09-24
07613154599240NA59200003075920-000-3072018-09-24
07613154615513NA59200003095920-000-3092018-09-24
07613252254430VertaPlex04066220000406-622-0002016-09-23
07613327141771SpinePlex040622200004062220002016-09-23
07613327141788SpinePlex04062020100406-202-0102016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08031497002842MectaCem BonePrepTECRES SPAJDK2022-11-17
07630345710963MectaPlug PE IIMedacta International SAJDK2021-04-16
07630345710970MectaPlug PE IIMedacta International SAJDK2021-04-16
07630345710987MectaPlug PE IIMedacta International SAJDK2021-04-16
07630345710994MectaPlug PE IIMedacta International SAJDK2021-04-16
07630345711007MectaPlug PE IIMedacta International SAJDK2021-04-16
08053369431048Emotec srlEMOTEC SRLJDK2021-02-03
00840019908757ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908764ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908771ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908788ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908795ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908801ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908818ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908825ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908832ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908849ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908856ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908863ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908870ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908887ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908894ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908900ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00815362022122ShurFit ACIF Titanium PRECISION SPINE, INC.JDK2019-03-28
00840019929233ShurFit ACIF Titanium PRECISION SPINE, INC.JDK2019-03-28
00840019929257ShurFit ACIF Titanium PRECISION SPINE, INC.JDK2019-03-28
00840019929240ShurFit ACIF Titanium PRECISION SPINE, INC.JDK2019-03-27
00840019929264ShurFit ACIF Titanium PRECISION SPINE, INC.JDK2019-03-27
00840019929271ShurFit ACIF Titanium PRECISION SPINE, INC.JDK2019-03-27
08031497001401Cement RestrictorTECRES SPAJDK2015-10-12