FDA.report

TSX®

Primary DI
00844868047292
Brand
TSX®
Company
ZimVie US Corp LLC
Model
TSXTAP47
Catalog number
N/A
Device description
TSX® BONE TAP, 4.7MM(D)
Published
2026-01-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00844868047292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00844868047292008448680472928448680472920844868047292

GMDN Terms

TermDefinition
Bone tap, reusableA surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. This is a reusable device.

Device Sizes

TypeValueUnit
Width4.7Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)342-5454dentalCS@zimvie.com

Regulatory Flags

DUNS number
119287313
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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00889024499720SwissPlus®DMSW32026-02-27
00889024499737SwissPlus®DMSW42026-02-27
00889024499744SwissPlus®DMT22026-02-27
00889024499751SwissPlus®DMT2S2026-02-27
00889024499768SwissPlus®DMT32026-02-27
00889024499775SwissPlus®DMT3S2026-02-27
00889024499782SwissPlus®DMT42026-02-27
00889024499799SwissPlus®DMT4S2026-02-27
00889024499805SwissPlus®DMT62026-02-27
00889024499812SwissPlus®DMT6S2026-02-27
00844868047261TSX® TSXTAP31N/A2026-01-21
00844868047278TSX® TSXTAP37N/A2026-01-21
00844868047285TSX® TSXTAP412026-01-21
00844868047308TSX® TSXTAP54N/A2026-01-21
00844868047315TSX® TSXTAP60N/A2026-01-21
00844868047322Tapered Screw-Vent® STRKIT2024-02-13
00844868048770TSX® TAPTRAY2025-11-21
00844868048800TSX® TSXBPROTRAY2025-11-21
00844868048862TSX® TSXRESTORTRAY2025-11-21

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