← Back to catalogue

STORM NON STERILE operating kit

FDA UDIEUDAMED

Class II (US FDA UDI)

by Metaphysis Llp

Identity

Trade Name
STORM NON STERILE operating kit FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
NON STERILE STORM OPERATING KIT: Pack of 5 FDA UDI
Model / Reference
1-10-0 FDA UDI
Description
NON STERILE STORM OPERATING KIT: Pack of 5 FDA UDI

Identifiers

Catalog Number
1-10-0 FDA UDI
Primary DI / UDI-DI
05060309870297 FDA UDI
510(k) Number
K061607 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

No

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

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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

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

STORM NON STERILE operating kit by Metaphysis Llp — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Metaphysis Llp

Sources (2)

  • FDA UDI c6f93204-711e-4161-a9b8-f1535bea892c 36 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 2, 2026