FDA.reportPublic FDA data

Medtronic Reusable Instruments

Primary DI
00613994966292
Brand
Medtronic Reusable Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
5480055
Device description
TAP 5480055 5.5 DUAL LEAD TAP
Published
2022-10-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXTTAPE, ORTHOPEDIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXTTape, OrthopedicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994966292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994966292006139949662926139949662920613994966292

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA metal surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached. It will typically be manually rotated in order to create a best possible thread. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000674397MSB Reusable Instruments98700052026-10-23
00763000749903CD HORIZON® Fenestrated Screw Spinal System557510245302026-10-23
00763000750510CD HORIZON® Fenestrated Screw Spinal System557510275502026-10-23
00763000777500MSB CD HORIZON Spinal System557500465352026-10-25
00763000777616CD HORIZON® Fenestrated Screw Spinal System557500475452026-10-23
00763000777623MSB CD HORIZON Spinal System557500475502026-10-25
00763000786434MSB CD HORIZON Spinal System65305302026-10-25
00763000857783T2 STRATOSPHERE™ Expandable Corpectomy System436125C2026-10-25
00763000874360MSB SHILLA Growth Guidance System76704312026-10-23
00763000880118MSB Reusable Instruments79670112026-10-23
00199150076451Medtronic Reusable InstrumentsX36902502026-10-19
00199150080373Medtronic Reusable InstrumentsX02260452026-10-19
00199150080380Medtronic Reusable InstrumentsX02260462026-10-19
00199150080397Medtronic Reusable InstrumentsX02260472026-10-19
00199150080403Medtronic Reusable InstrumentsX02260502026-10-19
00824846003922Medtronic Reusable InstrumentsEX06260022026-10-19
00824846013082Medtronic Reusable InstrumentsX09074302026-10-19
00824846013600Medtronic Reusable InstrumentsX07260042026-10-19
00763000750053CD HORIZON® Fenestrated Screw Spinal System557510245402026-10-16
00763000750251CD HORIZON® Fenestrated Screw Spinal System557510255302026-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00855459008059Pannus Retention SystemStetrix, Inc.HXT2025-01-10
00855459008080Panni Retractor SystemStetrix, Inc.HXT2025-01-10
00855459008004Pannus Retention SystemStetrix, Inc.HXT2025-01-10
10855459008049Pannus Retention SystemStetrix, Inc.HXT2025-01-10
10855459008056Pannus Retention SystemStetrix, Inc.HXT2025-01-10
10855459008087Panni Retractor SystemStetrix, Inc.HXT2025-01-10
00613994966230Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXT2022-10-17
00613994966308Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXT2022-10-17
00613994966315Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXT2022-10-17
00889024287372Anatomical Shoulder™Zimmer GmbHHXT2020-06-30
00760236206811MEIJERMEIJER, INC.HXT2020-06-22
10885403062919V. MuellerSTERIS CORPORATIONHXT2019-05-16