AccessGUDID - DEVICE: Solstice Occipito-Cervico-Thoracic System (00190837039103)

GUDID

Device Identifier (DI) Information

Brand Name: Solstice Occipito-Cervico-Thoracic System
Version or Model: 117-778
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 117-778
Company Name: Life Spine, Inc.

Primary DI Number: 00190837039103
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 183641617 *Terms of Use

Device Description: 3.5mm Rod Cutter

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):	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?
44805	Orthopaedic implantable-device cutter	A heavy-duty manual surgical instrument designed to hold and cut orthopaedic surgical implant devices (i.e., metal rods, plates, screws). The cutting is typically performed with a shearing action. It may be a hand-held or a table mounted device. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KWP	APPLIANCE, FIXATION, SPINAL INTERLAMINAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090343	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: c47aa339-44f4-4959-98ed-3364a617e9b8
Public Version Date: August 30, 2024
Public Version Number: 2
DI Record Publish Date: November 06, 2019