FDA.reportPublic FDA data

Pivot Guardian

Primary DI
37613327376396
Brand
Pivot Guardian
Company
STRYKER CORPORATION
Model
3105000701
Catalog number
3105-000-701
Device description
PostFree Patient Safety Kit, Medium
Published
2017-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613327376396PackageGS13In Commercial Distribution
07613327376395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761332737639637613327376396
07613327376395076133273763957613327376395

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
true
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
10809160522554HalyardAVID MEDICAL, INC.LRO2026-06-04
10809160522585HalyardAVID MEDICAL, INC.LRO2026-06-04
10809160522592HalyardAVID MEDICAL, INC.LRO2026-06-04
10809160522608HalyardAVID MEDICAL, INC.LRO2026-06-04
10809160522622HalyardAVID MEDICAL, INC.LRO2026-06-04
10885632522543SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-06-04
10198956346369CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956348950CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956363922CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956386099CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956390928CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956391437CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956399945CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956427693CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956434004CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956439436CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956441934CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956444119CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956463035CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956470071CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956471306CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956474703CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956477049CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956477759CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956478077CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956480841CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956482012CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956486683CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956489318CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956489585CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03