AccessGUDID - DEVICE: IngeniOS HA (04260476431319)

GUDID

Device Identifier (DI) Information

Brand Name: IngeniOS HA
Version or Model: 1-2mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1x1cc
Company Name: curasan AG

Primary DI Number: 04260476431319
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 324331826 *Terms of Use

Device Description: Device Name: IngeniOS HA Indications for Use: Oral-maxillofacial surgery, dentistry, implantology, periodontology • Defects after removal of bone cysts • Augmentation of the atrophied alveolar ridge • Sinus floor elevation (subantral augmentation) • Filling of alveolar defects following tooth extraction for alveolar ridge preservation • Filling of extraction defects to create an implant bed • Filling of two or multi-walled infrabony pockets, and bi and trifurcation defects • Support function for a membrane in guided tissue regeneration (GTR) • Defects after surgical removal of retained teeth or corrective osteotomies • Other multi-walled bone defects of the alveolar ridge

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:	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
LYC	Bone Grafting Material, Synthetic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K102872	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
No Device Sizes

Device Record Status

Public Device Record Key: 2818e50b-c5da-4513-8ac0-91176dc50858
Public Version Date: November 07, 2019
Public Version Number: 1
DI Record Publish Date: October 30, 2019