FDA.report

CUSTOM

Primary DI
03613720237488
Brand
CUSTOM
Company
MEDICREA INTERNATIONAL
Model
A99151175
Device description
CANNULATED SHARP POINTED TAP Ø7.5mm FOR 1/4 POWER ATTACHEMENT"
Published
2017-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HWXTap, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWXTap, BoneOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03613720237488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03613720237488036137202374883613720237488

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
383228632
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
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
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
03613720286714IB3D™ PL Spinal SystemA240002302025-02-24
03613720286677IB3D™ PL Spinal SystemA240000002025-02-21
03613720286684IB3D™ PL Spinal SystemA240002002025-02-21
03613720286707IB3D™ PL Spinal SystemA240002202025-02-21
03613720286202IB3D™ PL Spinal SystemB241C080622092025-02-15
03613720286219IB3D™ PL Spinal SystemB241C090622092025-02-15
03613720286226IB3D™ PL Spinal SystemB241C100622092025-02-15
03613720286233IB3D™ PL Spinal SystemB241C110622092025-02-15
03613720286240IB3D™ PL Spinal SystemB241C120622092025-02-15
03613720286257IB3D™ PL Spinal SystemB241C130622092025-02-15
03613720286264IB3D™ PL Spinal SystemB241C140622092025-02-15
03613720286271IB3D™ PL Spinal SystemB241C150622092025-02-15
03613720286288IB3D™ PL Spinal SystemB241C160622092025-02-15
03613720286295IB3D™ PL Spinal SystemB241C170622092025-02-15
03613720286301IB3D™ PL Spinal SystemB241C091222092025-02-15
03613720286318IB3D™ PL Spinal SystemB241C101222092025-02-15
03613720286325IB3D™ PL Spinal SystemB241C111222092025-02-15
03613720286332IB3D™ PL Spinal SystemB241C121222092025-02-15
03613720286349IB3D™ PL Spinal SystemB241C131222092025-02-15
03613720286356IB3D™ PL Spinal SystemB241C141222092025-02-15

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
G832F00503450ACURA Stabilization SystemBioalign Inc.HWX2026-03-09
G832F00503550ACURA Stabilization SystemBioalign Inc.HWX2026-03-09
G832F00503650ACURA Stabilization SystemBioalign Inc.HWX2026-03-09
03662663131674Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131681Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131698Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131704Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131711Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131728Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131735Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131803Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131810Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131827Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131834Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
10886982351661NASynthes GmbHHWX2026-02-11
10886982351678NASynthes GmbHHWX2026-02-11
00810112597417TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHWX2026-02-10
00810112597424TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHWX2026-02-10
00810112597431TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHWX2026-02-10
07640177821324Neo Medical Pedicle screw kitNeo Medical SAHWX2026-02-09
00199150055296Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-26
00199150055227Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055234Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055241Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055258Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055265Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055272Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055289Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055302Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055319Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25