AccessGUDID - DEVICE: DePuy Songer Spinal Cable System (10846468005235)

GUDID

Device Identifier (DI) Information

Brand Name: DePuy Songer Spinal Cable System
Version or Model: 400-206
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 7925016
Company Name: Pioneer Surgical Technology, Inc.

Primary DI Number: 10846468005235
Issuing Agency: GS1
Commercial Distribution End Date: August 23, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 793384496 *Terms of Use

Device Description: Bar, Round, Ti 2-Pack, NS, AcroMed

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?
44797	Internal spinal fixation system cable	An implantable fixation device designed to apply a force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. The device is typically made of braided medical grade titanium (Ti) and stainless steel alloy of various lengths and designs (e.g., it may be supplied with or without attached fasteners). The cable is tightened with a tension device and is fastened or crimped at each eye-type screw.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JDQ	CERCLAGE, FIXATION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K941213	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: edd93f20-f493-43b1-ba93-2cfe894737de
Public Version Date: August 26, 2024
Public Version Number: 7
DI Record Publish Date: December 10, 2015