AccessGUDID - DEVICE: Bosworth Aegis (H6680921328S1)

GUDID

Device Identifier (DI) Information

Brand Name: Bosworth Aegis
Version or Model: 0921328S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0921328S
Company Name: Harry J Bosworth Company

Primary DI Number: H6680921328S1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 014769301 *Terms of Use

Device Description: Aegis Pit & Fissure Sealant w/ACP 0.4 mL Sample

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?
31780	Dental pit/fissure sealant	A resin-based dental material suitable for sealing pits and fissures on teeth. It may be chemically cured or external energy cured. After application, this device cannot be reused.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EBC	SEALANT, PIT AND FISSURE, AND CONDITIONER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K033751	000

Device Exempt from Premarket Submission: No 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
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
Storage Environment Temperature: between 32 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 0.4 Milliliter

Device Record Status

Public Device Record Key: d839008e-c228-441b-b799-095a0333bc65
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 15, 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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