AccessGUDID - DEVICE: Niti#2 Wire, Blunt Blunt Tip, L=470, Ø1.5mm Over K-Wire (07290115935042)

GUDID

Device Identifier (DI) Information

Brand Name: Niti#2 Wire, Blunt Blunt Tip, L=470, Ø1.5mm Over K-Wire
Version or Model: 87865
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PREMIA SPINE LTD

Primary DI Number: 07290115935042
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 649220779 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63819	Spinal guidewire	A thin, non-implantable rod intended to guide the insertion of a cannulated orthopaedic implant (typically a screw) and/or surgical instrument (e.g., cannula, drill bit) during spinal surgery. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QWK	Prosthesis, Posterior Spinal Elements

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P220002	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3cf831aa-8ceb-46ea-9dcb-b6bc58435d12
Public Version Date: September 13, 2024
Public Version Number: 1
DI Record Publish Date: September 05, 2024