AccessGUDID - DEVICE: ENDOSKELETON Posterior DPK (M682110000110)

GUDID

Device Identifier (DI) Information

Brand Name: ENDOSKELETON Posterior DPK
Version or Model: 1100-0011
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1100-0011
Company Name: TITAN SPINE, LLC

Primary DI Number: M682110000110
Issuing Agency: HIBCC
Commercial Distribution End Date: September 21, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 623316978 *Terms of Use

Device Description: 90 Deg Reverse Angle (Push), Bayonet, Cup Curette, Medium

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
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Device Size Text, specify: Disc Prep Kit, Bayonet Cup Curette, 90 Deg Reverse Angled (Push), Medium
Length: 15 Inch

Device Record Status

Public Device Record Key: d1e84d86-a908-4de1-a376-c42bd763838d
Public Version Date: December 09, 2020
Public Version Number: 5
DI Record Publish Date: September 17, 2016