AccessGUDID - DEVICE: Preference Pedicle Screw System (00841732151024)

GUDID

Device Identifier (DI) Information

Brand Name: Preference Pedicle Screw System
Version or Model: 10-2900-045
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CTL Medical Corporation

Primary DI Number: 00841732151024
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080138504 *Terms of Use
Previous DI: M555102900045

Device Description: Cross Connector 45mm Variable Length (37mm-45mm)

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):	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?
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
KWQ	Appliance, Fixation, Spinal Intervertebral Body
MNI	Orthosis, Spinal Pedicle Fixation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K081296	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: 75f86440-5823-48f3-aa06-a700220b135a
Public Version Date: November 18, 2024
Public Version Number: 2
DI Record Publish Date: September 27, 2024