AccessGUDID - DEVICE: CB TRIP (D785ISIC2933250)

GUDID

Device Identifier (DI) Information

Brand Name: CB TRIP
Version or Model: 2.9,3.0 & 3.25mm C&B IMPRESSION PICKUP 2.9,3.0 & 3.25MM C&B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ISIC 2.9/3/3.25
Company Name: OCO BIOMEDICAL INC

Primary DI Number: D785ISIC2933250
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 094146123 *Terms of Use

Device Description: 2.9,3.0 & 3.25mm CROWN AND BRIDGE IMPRESSION PICKUP

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?
64323	Dental implant abutment impression cap	A small device intended to be placed intraorally on the abutment head of a dental implant during a dental impression to facilitate removal of the impression material once it has hardened, and to reproduce the intraoral position and orientation of the abutment/implant in a dental laboratory working model, for the fabrication of a final dental prosthesis (e.g., denture). 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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 0657d84f-5f8a-4e54-a34a-a64051fc72f9
Public Version Date: March 05, 2024
Public Version Number: 1
DI Record Publish Date: February 26, 2024