AccessGUDID - DEVICE: Symbios ™ (EFRIUS99U000102)

GUDID

Device Identifier (DI) Information

Brand Name: Symbios ™
Version or Model: PepGen P-15 Particulate
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: US99U000102
Company Name: Dentsply Implants Manufacturing GmbH

Primary DI Number: EFRIUS99U000102
Issuing Agency: HIBCC
Commercial Distribution End Date: November 01, 2015
Device Count: 2
Labeler D-U-N-S® Number*: 344038836 *Terms of Use

Device Description: No description.

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":	Yes
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?
47968	Dental bone matrix implant, animal-derived	A sterile bioabsorbable device made primarily of animal-derived bone or dentin matrix (e.g., bovine, porcine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is used to fill bone cavities and defects and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile cancellous blocks, chips, or granules of varying sizes, or mouldable materials.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NPZ	Bone grafting material, dental, with biologic component

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: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Weight: 1 Gram

Device Record Status

Public Device Record Key: 5f56e794-3cb8-4bde-9557-3f33da598d0d
Public Version Date: October 13, 2023
Public Version Number: 3
DI Record Publish Date: December 02, 2014