AccessGUDID - DEVICE: Plasdent (D832RDS120)

GUDID

Device Identifier (DI) Information

Brand Name: Plasdent
Version or Model: RDS-12
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RDS-12
Company Name: PLASDENT CORPORATION

Primary DI Number: D832RDS120
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 190377184 *Terms of Use

Device Description: Dental Dam Stabilizing Cord, 6 5/6 ft, Dia: 1.88 mm (Medium)

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):	No
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?
45079	Rubber dam stabilization cord, Hevea-latex	A length of elastomeric material made of Hevea natural rubber latex (NRL) designed to stabilize/secure a rubber dam in the oral cavity during routine operative and endodontic procedures. It can be used wedge-like between the teeth and/or tied around a tooth to anchor a rubber dam to the cervical region of an exposed tooth. This device is available in a variety of sizes and may help reduce the trauma and discomfort perceived by some patients caused through the use of metal clamps. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NRD	Unit, Operative Dental, Accessories

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: 361c7dd0-a6ef-4364-97f8-02206b1fef73
Public Version Date: June 14, 2023
Public Version Number: 1
DI Record Publish Date: June 06, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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