Pivot Guardian

Primary DI
37613327419031
Brand
Pivot Guardian
Company
STRYKER CORPORATION
Model
3105000732
Catalog number
3105-000-732
Device description
Pivot Guardian Disposable Kit, Large
Published
2018-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PXNBasic set-up tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PXNBasic Set-Up TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613327419031PackageGS13In Commercial Distribution
07613327419030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761332741903137613327419031
07613327419030076133274190307613327419030

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)624-4422xx@xx.xx

Regulatory Flags#

DUNS number
187502109
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613252254430VertaPlex04066220000406-622-0002016-09-23
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
07613327141771SpinePlex040622200004062220002016-09-23
07613327141788SpinePlex04062020100406-202-0102016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956011175CARDINAL HEALTHCardinal Health 200, LLCPXN2025-04-17
50198956011173CARDINAL HEALTHCardinal Health 200, LLCPXN2025-04-17
10197106955222CARDINAL HEALTHCardinal Health 200, LLCPXN2025-03-25
50197106955220CARDINAL HEALTHCardinal Health 200, LLCPXN2025-03-25
10304040166618Henry ScheinHENRY SCHEIN, INC.PXN2023-07-30
10304040167707Henry ScheinHENRY SCHEIN, INC.PXN2023-07-30
10304040167899Henry ScheinHENRY SCHEIN, INC.PXN2023-07-30
00304040166611Henry ScheinHENRY SCHEIN, INC.PXN2023-07-30
00304040167700Henry ScheinHENRY SCHEIN, INC.PXN2023-07-30
00304040167892Henry ScheinHENRY SCHEIN, INC.PXN2023-07-30
10197106298473CARDINAL HEALTHCardinal Health 200, LLCPXN2023-07-11
50197106298471CARDINAL HEALTHCardinal Health 200, LLCPXN2023-07-11
00191375051374ENDOSKELETON®TITAN SPINE, LLCPXN2020-02-17
00191375051381ENDOSKELETON®TITAN SPINE, LLCPXN2020-02-17
00191375051398ENDOSKELETON®TITAN SPINE, LLCPXN2020-02-17
00191375051411ENDOSKELETON®TITAN SPINE, LLCPXN2020-02-17
00191375051428ENDOSKELETON®TITAN SPINE, LLCPXN2020-02-17
00191375051480ENDOSKELETON®TITAN SPINE, LLCPXN2020-02-17
00191375051749ENDOSKELETON®TITAN SPINE, LLCPXN2020-02-17
00191375051756ENDOSKELETON®TITAN SPINE, LLCPXN2020-02-17
00191375051763ENDOSKELETON®TITAN SPINE, LLCPXN2020-02-17
00191375052838ENDOSKELETON® TATITAN SPINE, LLCPXN2020-02-17
00191375052845ENDOSKELETON® TATITAN SPINE, LLCPXN2020-02-17
07613327419023Pivot GuardianSTRYKER CORPORATIONPXN2018-12-07
07613327419030Pivot GuardianSTRYKER CORPORATIONPXN2018-12-07
07613327419047Pivot GuardianSTRYKER CORPORATIONPXN2018-12-07
37613327419024Pivot GuardianSTRYKER CORPORATIONPXN2018-12-07
37613327419048Pivot GuardianSTRYKER CORPORATIONPXN2018-12-07