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
00199150072668Medtronic Reusable InstrumentsEX20260152026-08-09
00199150083459Medtronic Reusable InstrumentsEX65500002026-08-08
00199150083466Medtronic Reusable InstrumentsEX65500062026-08-08
00199150076468Medtronic Reusable InstrumentsX46810082026-08-03
00199150076475Medtronic Reusable InstrumentsX46820082026-08-03
00199150076482Medtronic Reusable InstrumentsX46800202026-08-03
00199150076499Medtronic Reusable InstrumentsX46800212026-08-03
00199150083473Medtronic Reusable InstrumentsEX75709002026-08-03
00763000858063T2 STRATOSPHERE™ Expandable Corpectomy System4361254002026-08-01
00763000992026MSB CD HORIZON Spinal SystemX04150662026-08-02
00199150081073Medtronic Reusable InstrumentsX04260042026-07-30
00199150081905Medtronic Reusable InstrumentsX04260022026-07-30
00199150083107Medtronic Reusable InstrumentsEX10040072026-07-30
00199150083879Medtronic Reusable InstrumentsX09074112026-07-30
00763000887216MSB CD HORIZON Spinal System65435352026-07-30
00721902975158GDLH® Posterior Spinal SystemX0196-1112015-08-05
00721902975189GDLH® Posterior Spinal SystemX0196-1222015-08-05
00721902975219GDLH® Posterior Spinal SystemX0196-1262015-08-05
00721902975226GDLH® Posterior Spinal SystemX0196-1282015-08-05
00721902975233GDLH® Posterior Spinal SystemX0196-1302015-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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