AccessGUDID - DEVICE: neon³™ OCT spinal stabilization (04052536161614)

GUDID

Device Identifier (DI) Information

Brand Name: neon³™ OCT spinal stabilization
Version or Model: CS 3917-09
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CS 3917-09
Company Name: Ulrich GmbH & Co. KG

Primary DI Number: 04052536161614
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315494757 *Terms of Use

Device Description: Crosslink, screw to screw, M

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
65114	Bone-screw internal spinal fixation system connector	An implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWP	APPLIANCE, FIXATION, SPINAL INTERLAMINAL
NKG	Orthosis, cervical pedicle screw spinal fixation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161032	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: 138e4f26-4aaf-4077-8eaf-4c5eda10ad33
Public Version Date: September 11, 2024
Public Version Number: 5
DI Record Publish Date: February 14, 2018