AccessGUDID - DEVICE: Dentronix (D661D5000ST0)

GUDID

Device Identifier (DI) Information

Brand Name: Dentronix
Version or Model: D5000S-T
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DENTRONIX INC

Primary DI Number: D661D5000ST0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 085690428 *Terms of Use

Device Description: Horizontal Tray

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?
35364	Dry-heat sterilizer	A mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from non-heat sensitive medical devices and related products using dry heat sterilization. It typically includes a treatment chamber with shelves where the devices to be sterilized are placed, usually after cleaning of gross debris; a heat source (e.g., electric heaters); and controls to regulate the time and/or temperature of the procedure. The heat may flow into the chamber either by natural convection or using forced air to accelerate and/or make more uniform the process (e.g., fans, high-speed hot air jets). The device is available in stand-alone (bulk) and tabletop units.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KMH	Sterilizer, Dry Heat

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051660	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8da69a7e-8417-4347-a36d-fa73d436b581
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 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: No
Manufacturing Date: Yes
Donation Identification Number: Yes CLOSE

Customer Contact

[?]

Phone: 330-916-7300
Email: info@dentronix.com

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