AccessGUDID - DEVICE: 4.5mm BONE-LOK PLS Implant (81195401002786)

GUDID

Device Identifier (DI) Information

Brand Name: 4.5mm BONE-LOK PLS Implant
Version or Model: LSW-45-3040
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 9024-00
Company Name: INTERVENTIONAL SPINE, INC

Primary DI Number: 81195401002786
Issuing Agency: GS1
Commercial Distribution End Date: December 23, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 017663522 *Terms of Use

Device Description: 4.5mm O.D. x 30-40mm Length

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
61324	Bone-screw internal spinal fixation system, sterile	An assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MRW	System, Facet Screw Spinal Device

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: 7b7b98fe-a75f-4735-a1ae-0fc66b8e1ad9
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 14, 2015