AccessGUDID - DEVICE: BENCO (00366975005144)

GUDID

Device Identifier (DI) Information

Brand Name: BENCO
Version or Model: 5095-505
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BENCO DENTAL SUPPLY CO.

Primary DI Number: 00366975005144
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015108087 *Terms of Use

Device Description: Burnisher DE #21B

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):	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?
35785	Dental burnisher	A rotary dental device with a smooth or ribbed working head used to create thin margins between a restoration and the enamel at the cavo-surface angle, and/or to polish the surface of metallic restorations by rubbing. It's terminus may be flat, ball, or beavertail. It is available according to the material used in the restoration (e.g., amalgam, gold alloy). This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HTC	Pliers, Surgical

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: 37a1e6ea-9f6c-492f-b4c1-22c0ef54d9ae
Public Version Date: December 03, 2018
Public Version Number: 1
DI Record Publish Date: November 01, 2018

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: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 570-602-6924
Email: jsoroka@benco.com

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