AccessGUDID - DEVICE: Aseptico (10817417022306)

GUDID

Device Identifier (DI) Information

Brand Name: Aseptico
Version or Model: AEU-350
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AEU-350
Company Name: ASEPTICO, INC.

Primary DI Number: 10817417022306
Issuing Agency: GS1
Commercial Distribution End Date: July 31, 2030
Device Count: 1
Labeler D-U-N-S® Number*: 016853348 *Terms of Use

Device Description: AEU-350 Portable Dentistry System

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?
34991	Dental delivery system	A stationary, mains electricity (AC-powered) device assembly designed to provide dental staff with the necessary utilities/amenities to deliver dental treatment to a patient. The utilities/amenities are typically compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor, gas, and sometimes the dental light. This is a fixed-position system (i.e., not mobile) which incorporates an instrument unit for dental instrument provision. The patient examination/treatment chair is typically integrated as part of this system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIA	Unit, Operative Dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130693	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Humidity: between 10 and 28 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6edf2f4e-1f5b-46fc-b507-2b86ee2cb307
Public Version Date: September 08, 2021
Public Version Number: 1
DI Record Publish Date: August 31, 2021

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

Customer Contact

[?]

Phone: 425-487-3157
Email: Regulatory@aseptico.com

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