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STORM Sterile Operating Kit

FDA UDI

Class II (US FDA UDI)

by Metaphysis Llp

Identity

Trade Name
STORM Sterile Operating Kit FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
Sterile Storm Operating Kit FDA UDI
Model / Reference
1-10-10 FDA UDI
Description
Sterile Storm Operating Kit FDA UDI

Identifiers

Primary DI / UDI-DI
05060309870013 FDA UDI
FDA Product Code
HWC FDA UDI
HTY FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthopaedic surgical procedure kit, non-medicated, single-use

STORM Sterile Operating Kit by Metaphysis Llp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Metaphysis Llp

Sources (1)

  • FDA UDI a64a6451-66ea-46ea-a6dc-eef0c34e2887 33 fields · synced May 30, 2026