FDA UDI In Commercial Distribution 🇺🇸 United States

STORM Sterile Operating Kit

DI: 05060309870013 · Model: 1-10-10 · METAPHYSIS LLP
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
STORM Sterile Operating Kit
Primary DI
05060309870013
Version / Model
1-10-10
Company Name
METAPHYSIS LLP
Labeler DUNS
219570490
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-23
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
a64a6451-66ea-46ea-a6dc-eef0c34e2887

Device Description

Sterile Storm Operating Kit

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
Yes
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
HWC Screw, Fixation, Bone
HTY Pin, Fixation, Smooth

GMDN Terms

Code Name
44052 Orthopaedic surgical procedure kit, non-medicated, single-use

Identifiers

Type ID
Package 5060309870020
Primary 05060309870013