AccessGUDID - DEVICE: NEOTIS (03760154002301)

GUDID

Device Identifier (DI) Information

Brand Name: NEOTIS
Version or Model: NEOTIS 50
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: HTO2667M15
Company Name: S.B.M

Primary DI Number: 03760154002301
Issuing Agency: GS1
Commercial Distribution End Date: January 09, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 772462123 *Terms of Use

Device Description: Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 45% porosity

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?
16966	Synthetic bone graft	An artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MQV	Filler, Bone Void, Calcium Compound

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130953	000

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
Height: 15 Millimeter

Device Record Status

Public Device Record Key: 6efbe82e-c481-4a11-85dc-317dbf1f7307
Public Version Date: December 11, 2023
Public Version Number: 7
DI Record Publish Date: October 14, 2015