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Oasys

FDA UDI

Class I (US FDA UDI)

by Stryker Corp.

Identity

Trade Name
OASYS FDA UDI
Generic Name
Orthopaedic counter-torque/rod-pushing instrument FDA UDI
Device Name
FIXED DRILL GUIDE FDA UDI
Model / Reference
48562035 FDA UDI
Description
FIXED DRILL GUIDE FDA UDI

Identifiers

Catalog Number
48562035 FDA UDI
Primary DI / UDI-DI
07613327271720 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic counter-torque/rod-pushing instrument 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 14.0 Millimeter FDA UDI

Category: Orthopaedic counter-torque/rod-pushing instrument

Oasys by Stryker Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic counter-torque/rod-pushing instrument.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Corp.

Sources (1)

  • FDA UDI 66e90915-f93d-4519-aa6d-345d3b1aa822 35 fields · synced May 30, 2026