AccessGUDID - DEVICE: BOSWORTH (H668166901)

GUDID

Device Identifier (DI) Information

Brand Name: BOSWORTH
Version or Model: 16690
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 16690
Company Name: Keystone Industries

Primary DI Number: H668166901
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 073503117 *Terms of Use

Device Description: PROPHY POWDER GRAPE (10 OZ)

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?
45407	Professional dental abrasive material	A dental material made from various base substances having some abrasive qualities [e.g., treated sodium bicarbonate (NaHCO3) or aluminium oxide (Al2O3)] and applied by a healthcare professional with an appropriate device (e.g., a dental abrasive air jet system) to the surface of teeth or dental devices (e.g., restorations). It has a wide variety of both prophylactic and treatment applications such as the removal of plaque and stains, cleaning fissures (above and below the gingiva), the preparation of a tooth surface prior to bonding, cleaning orthodontic appliances (bands and brackets), removing adhesive residue, and cleaning implants prior to loading. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJR	AGENT, POLISHING, ABRASIVE, ORAL CAVITY

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
Storage Environment Temperature: between 32 and 86 Degrees Fahrenheit
Special Storage Condition, Specify: Keep out of direct sunlight
Special Storage Condition, Specify: Keep away from moisture
Storage Environment Temperature: between 0 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 284 Gram

Device Record Status

Public Device Record Key: aa649999-8bec-4e0d-980b-4e8fbac45b9b
Public Version Date: August 18, 2025
Public Version Number: 2
DI Record Publish Date: November 30, 2022

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

Customer Contact

[?]

Phone: +1(800)333-3131 ext: 8455
Email: tschwear@keystoneind.com

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