FDA.reportPublic FDA data

Pivot Guardian

Primary DI
07613327419047
Brand
Pivot Guardian
Company
STRYKER CORPORATION
Model
3105000731
Catalog number
3105-000-731
Device description
Pivot Guardian Disposable Kit, Medium
Published
2018-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
37613327419048PackageGS13In Commercial Distribution
07613327419047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761332741904837613327419048
07613327419047076133274190477613327419047

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.

Contacts#

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

Regulatory Flags#

DUNS number
187502109
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327524475Optablate97000151009700-015-1002022-09-23
07613327638233Omnicurve10320150001032-015-0002024-09-03
00857037006075LATERALATSYS24LATSYS242020-01-14
00857037006037LATERALATSYS20LATSYS202020-01-08
07613327060058Precision Ideal Eyes05028190100502-819-0102016-09-23
07613327006223ARIA48755700487557002019-11-20
07613327006919ES2 SPINAL SYSTEM48280082482800822019-11-20
07613327006926ES2 SPINAL SYSTEM48280083482800832019-11-20
07613327006940ES2 SPINAL SYSTEM48280086482800862019-11-20
07613327006957ES2 SPINAL SYSTEM48280087482800872019-11-20
07613327007114ES2 SPINAL SYSTEM48280311482803112019-11-25
07613327007558XIA 348237078482370782019-11-25
07613327007565XIA 348237079482370792019-11-25
07613327067088ACCULIF8003578003572016-09-24
07613327067095ACCULIF8003478003472016-09-24
07613327114799XIA 4.5 EVOLUTION48138140481381402019-11-21
07613327114812XIA 4.5 EVOLUTION48138011R48138011R2019-11-20
07613327114843XIA 4.5 EVOLUTION48138011L48138011L2019-11-20
07613327114850XIA 4.5 EVOLUTION48138101481381012019-11-21
07613327114874ES2 SPINAL SYSTEM48280178482801782019-11-20

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
37613327419024Pivot GuardianSTRYKER CORPORATIONPXN2018-12-07
37613327419031Pivot GuardianSTRYKER CORPORATIONPXN2018-12-07
37613327419048Pivot GuardianSTRYKER CORPORATIONPXN2018-12-07