DEVICE: STORM NON STERILE operating kit (05060309870297)

Device Identifier (DI) Information

STORM NON STERILE operating kit
1-10-0
In Commercial Distribution
1-10-0
METAPHYSIS LLP
05060309870297
GS1

1
219570490 *Terms of Use
No description.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Orthopaedic surgical procedure kit, non-medicated, single-use A collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
HWC Screw, Fixation, Bone
HTY Pin, Fixation, Smooth
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K061607 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

c6f93204-711e-4161-a9b8-f1535bea892c
July 06, 2018
3
September 23, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+4408458004405
info@io-uk.com
CLOSE