AccessGUDID - DEVICE: ENDOSKELETON® DPK (00191375030645)

GUDID

Device Identifier (DI) Information

Brand Name: ENDOSKELETON® DPK
Version or Model: 1900-0003
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1900-0003
Company Name: TITAN SPINE, LLC

Primary DI Number: 00191375030645
Issuing Agency: GS1
Commercial Distribution End Date: September 18, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 623316978 *Terms of Use

Device Description: Disc Prep Kit, Posterior, Ring Curette, 8mm

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?
31335	Bone curette, reusable	A manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MAX	Intervertebral fusion device with bone graft, lumbar

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K083714	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
Length: 14 Inch
Height: 8 Millimeter

Device Record Status

Public Device Record Key: 324b16e4-d6c9-4da7-a711-7e98dfc324c8
Public Version Date: December 09, 2020
Public Version Number: 4
DI Record Publish Date: September 30, 2019