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DualXS Implant Retainer Shaft Long

FDA UDI

Class II (US FDA UDI)

by Amplify Surgical

Identity

Trade Name
DualXS Implant Retainer Shaft Long FDA UDI
Generic Name
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Device Name
DUALXS IMPLANT RETAINER SHAFT LONG FDA UDI
Model / Reference
12844008 FDA UDI
Description
DUALXS IMPLANT RETAINER SHAFT LONG FDA UDI

Identifiers

Primary DI / UDI-DI
B707128440080 FDA UDI
FDA Product Code
MAX FDA UDI
GMDN Term
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic inorganic implant inserter/extractor, reusable

DualXS Implant Retainer Shaft Long by Amplify Surgical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic inorganic implant inserter/extractor, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Amplify Surgical

Sources (1)

  • FDA UDI b4b0fb39-5ac4-4e98-bb74-852534a50d2e 34 fields · synced May 30, 2026