AccessGUDID - DEVICE: OCO LOK BLOCK OUT SPACER (D785LOKPD40)

GUDID

Device Identifier (DI) Information

Brand Name: OCO LOK BLOCK OUT SPACER
Version or Model: OCO LOK BLOCK OUT SPACER
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LOK PD-4
Company Name: OCO BIOMEDICAL INC

Primary DI Number: D785LOKPD40
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 094146123 *Terms of Use

Device Description: OCO LOK BLOCK OUT SPACER (4-PK)

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?
44575	Dental impression spacer	A device comprised of thin layers of wax or other plastic materials intended to be applied to the surface of edentulous ridges and dental structures before the preliminary application of impression material. After producing the preliminary model, the device is discarded, thus providing an equidistant space between the oral structures and the impression tray that allows escape of excess impression material and entrapped air, and facilitates manipulation during final impression taking. 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: 1b82395c-fcf7-45cd-8bc2-bf4bc544891f
Public Version Date: March 20, 2024
Public Version Number: 1
DI Record Publish Date: March 12, 2024