AccessGUDID - DEVICE: DDP - Columbia/Buccal Retractor 14.5cm (00083208136610)

GUDID

Device Identifier (DI) Information

Brand Name: DDP - Columbia/Buccal Retractor 14.5cm
Version or Model: Retractor Columbia/Buccal 14.5cm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Retractor Columbia/Buccal 14.5cm
Company Name: Suncoast Dental, Inc

Primary DI Number: 00083208136610
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078352849 *Terms of Use

Device Description: The Columbia retractor is double ended and used to hold cheeks and lips away from the surgical area during a procedure for better visibility. Can also be used for dental photography. This is a reusable device.

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:	No
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?
13380	Hand-held dental retractor	A hand-held, non-self-retaining dental instrument intended to be used to manually displace soft tissues of the oral cavity to improve their visualization and access, and to afford them protection during oral surgical procedures. It is typically a metallic device and includes a shaped/hooked blade with a handle/holding portion. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIG	Retractor, All Types

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: 3a2dc2a0-29d0-4ecb-a87e-9fe3c72febcc
Public Version Date: December 16, 2022
Public Version Number: 1
DI Record Publish Date: December 08, 2022