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Riptide

FDA UDI

Class I (US FDA UDI)

by Tyber Medical

Identity

Trade Name
RIPTIDE FDA UDI
Generic Name
Orthopaedic inorganic implant inserter/extractor, single-use FDA UDI
Device Name
Cotton Instrument Kit Sterile FDA UDI
Model / Reference
6ZBC00000 FDA UDI
Description
Cotton Instrument Kit Sterile FDA UDI

Identifiers

Catalog Number
6ZBC00000 FDA UDI
Primary DI / UDI-DI
00196449002429 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic inorganic implant inserter/extractor, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: Orthopaedic inorganic implant inserter/extractor, single-use

Riptide by Tyber Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic inorganic implant inserter/extractor, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tyber Medical

Sources (1)

  • FDA UDI b756885c-61aa-4fbc-8d30-d98682aec465 35 fields · synced Jun 8, 2026