AccessGUDID - DEVICE: HOUSING CAP WITH BLK ORING (D785003CAPWO0)

GUDID

Device Identifier (DI) Information

Brand Name: HOUSING CAP WITH BLK ORING
Version or Model: 003 CAP WITH 003 BLK O-RING INSERTED
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 003 CAP W/O-RING
Company Name: OCO BIOMEDICAL INC

Primary DI Number: D785003CAPWO0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 094146123 *Terms of Use

Device Description: 003 CAP WITH 003 BLK O-RING INSERTED

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?
38625	Denture clasp, polymer, preformed	A prefabricated dental device made of polymer material intended to retain and stabilize a removable partial denture to stationary teeth. It is manufactured to meet a standard specification for adaptation or direct insertion into the patient's mouth.	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: 9fbda4de-4d6a-41d2-8df1-0841b368050a
Public Version Date: April 04, 2024
Public Version Number: 2
DI Record Publish Date: March 12, 2024