AccessGUDID - DEVICE: 2.9 SDI C&B PROSTHETIC KIT (D78529SDICBPK0)

GUDID

Device Identifier (DI) Information

Brand Name: 2.9 SDI C&B PROSTHETIC KIT
Version or Model: 2.9MM SDI C&B PROSTHETIC KIT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2.9 SDI-CB PK
Company Name: OCO BIOMEDICAL INC

Primary DI Number: D78529SDICBPK0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 094146123 *Terms of Use

Device Description: 2.9MM SDI C&B PROSTHETIC KIT

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:	Yes
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?
64312	Dental prosthesis/implant abutment screw analog, single-use	A device intended to be used as a copy of a dental implant prosthetic screw to attach a dental implant abutment or prosthesis (e.g., crown, bridge) to a dental implant analog in a dental laboratory working model. Some types are referred to as a guide pin, and may be used intraorally to attach an implant coping to the dental implant during an open-tray impression procedure. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device.	Active	false
61642	Dental implant analog	A device intended to be used as a copy of a dental implant, for a dental laboratory working model, to duplicate the location and restorative platform orientation of the final dental implant; it is not intended for intraoral use. It is a rod-like device made of metal [e.g., titanium (Ti)]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NDP	Accessories, Implant, Dental, Endosseous

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: 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: 691b5737-aa92-464e-a49d-8250f7c02c61
Public Version Date: March 06, 2024
Public Version Number: 1
DI Record Publish Date: February 27, 2024