AccessGUDID - DEVICE: NIDO Pedicle Screw System (B07315K0430210)

GUDID

Device Identifier (DI) Information

Brand Name: NIDO Pedicle Screw System
Version or Model: 15-K04-3021
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 15-K04-3021
Company Name: Kalitec Direct LLC

Primary DI Number: B07315K0430210
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041956211 *Terms of Use

Device Description: Sagittal Bender, Double Ended Right

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:	No
Prescription Use (Rx):	No
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?
60741	Spinal rod bending system	An assembly of mains electricity (AC-powered) computerized devices intended to be used to determine the relative locations of internal spinal fixation system implants (e.g., screws, hooks) for the production of bend instructions to shape a spinal rod during spinal fusion surgery. It primarily consists of an electronic spatial measurement system used with manual tools to determine implant location and to take measurements; computer/software to convert implant locations to a series of bend instructions; and an orthopaedic rod bender to execute bend instructions. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HXW	Bender

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 85759b4e-2c21-414a-828c-04954586cb88
Public Version Date: October 16, 2023
Public Version Number: 1
DI Record Publish Date: October 06, 2023