AccessGUDID - DEVICE: Bosworth (H66809217881)

GUDID

Device Identifier (DI) Information

Brand Name: Bosworth
Version or Model: 0921788
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0921788
Company Name: Harry J Bosworth Company

Primary DI Number: H66809217881
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 014769301 *Terms of Use

Device Description: 1 oz Bonding Liquid

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?
17609	Denture reliner, hard	A denture relining material intended to be applied by a dentist or dental laboratory technician as a permanent coating or lining on the base or tissue-contact surface of a denture and which sets to a hard state. Denture relining is defined as a process of providing a new fitting surface to a denture. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBI	RESIN, DENTURE, RELINING, REPAIRING, REBASING

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

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1 Fluid Ounce
Total Volume: 30 Milliliter

Device Record Status

Public Device Record Key: c2dd046b-d9d7-4e87-aa62-b618256db0a4
Public Version Date: August 09, 2018
Public Version Number: 3
DI Record Publish Date: November 11, 2016

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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