FDA.reportPublic FDA data

PASS LP

Primary DI
03613720224884
Brand
PASS LP
Company
MEDICREA INTERNATIONAL
Model
MS515
Device description
RATCHETING WRENCH FOR CLAW NUT
Published
2017-01-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HXCWrench

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXCWrenchOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03613720224884PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03613720224884036137202248843613720224884

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary 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 reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
383228632
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03613720249832PASS TLA220302002017-01-31
03613720286875UNiD OCTB33243600-01B33243600-012021-08-19
03613720286882UNiD OCTB33243500-01B33243500-012021-08-19
03613720286899UNiD OCTB33143600-01B33143600-012021-08-19
03613720286905UNiD OCTB33143500-01B33143500-012021-08-19
03613720286936UNiD RODB33136012-01B33136012-012021-08-19
03613720286943UNiD RODB33236012-01B33236012-012021-08-19
03613720268451UNiD RODB33125512-01B33125512-012017-06-12
03613720268468UNiD RODB33125512-02B33125512-022017-06-12
03613720268628UNiD RODB33225512-01B33225512-012017-06-12
03613720268635UNiD RODB33225512-02B33225512-022017-06-12
03613720268963UNiD RODB33126012-01B33126012-012017-08-28
03613720268970UNiD RODB33126012-02B33126012-022017-08-28
03613720269137UNiD RODB33226012-01B33226012-012017-08-28
03613720269144UNiD RODB33226012-02B33226012-022017-08-28
03613720269304UNiD OCTB33123500-01B33123500-012017-09-12
03613720269311UNiD OCTB33123500-02B33123500-022017-09-12
03613720269397UNiD OCTB33223500-01B33223500-012017-09-12
03613720269403UNiD OCTB33223500-02B33223500-022017-09-12
03613720286585UNiD MISB33155522-01B33155522-012021-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150072064Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXC2026-05-23
00840493416540LUX Expandable Interbody SystemXENIX MEDICAL LLCHXC2026-03-13
00888867500785Arthrex®ARTHREX, INC.HXC2026-03-13
00888867500808Arthrex®ARTHREX, INC.HXC2026-03-13
00888867500815Arthrex®ARTHREX, INC.HXC2026-03-13
00888867500853Arthrex®ARTHREX, INC.HXC2026-03-13
00199150065974Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXC2026-02-28
00190376731988IdentiTi IIALPHATEC SPINE, INC.HXC2026-02-18
03662663131636Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2026-02-11
03662663131643Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2026-02-11
03662663131650Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2026-02-11
00840180543948General InstrumentsALPHATEC SPINE, INC.HXC2025-12-31
03662663198202Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHXC2025-12-17
03662663216760Nex-Link OCT Occipital Cervical Plating SystemHighridge Medical, LLCHXC2025-12-17
03662663216777Nex-Link OCT Occipital Cervical Plating SystemHighridge Medical, LLCHXC2025-12-17
03662663191906Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2025-12-16
03662663136549Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2025-11-14
03662663136556Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2025-11-14
03662663136563Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2025-11-14
03662663137249Polaris 4.75 Deformity SystemHighridge Medical, LLCHXC2025-11-14
03662663161466The Tether Vertebral Body Tethering SystemHighridge Medical, LLCHXC2025-11-14
03662663192385InCompass Spinal Fixation SystemHighridge Medical, LLCHXC2025-11-14
03662663194129PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCHXC2025-11-14
00199150051199Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXC2025-11-13
00840314269768gSourceGSOURCE LLCHXC2025-08-29
00889797111195Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HXC2025-08-26
00889797111201Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HXC2025-08-26
00889797111218Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HXC2025-08-26
00889797111225Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HXC2025-08-26
00889797112642N/AWRIGHT MEDICAL TECHNOLOGY, INC.HXC2025-08-26