AccessGUDID - DEVICE: The Tether™ (03662663080835)

GUDID

Device Identifier (DI) Information

Brand Name: The Tether™
Version or Model: 240H6003
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 240H6003
Company Name: Highridge Medical, LLC

Primary DI Number: 03662663080835
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119260394 *Terms of Use

Device Description: Tether Reel Tensioner

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?
65554	Anterior spinal tethering system tether	An implantable, flexible band or cord that is a component of an anterior spinal tethering system and intended to provide restrictive force on one side of the spine to allow growth on the contralateral side, to help achieve straightening of the spine in the treatment of idiopathic scoliosis. It is designed as a longitudinal (intervertebral) component intended to be attached to adjacent vertebral body screws/anchors (not included).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
QHP	Vertebral body tethering system

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: 3c25e120-0bdd-4099-987b-1cc4cca6ac04
Public Version Date: February 14, 2025
Public Version Number: 1
DI Record Publish Date: February 06, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)447-3625
Email: usbrocustomerservice@highridgemedical.com

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