AccessGUDID - DEVICE: Alloy Melter (00841439111710)

GUDID

Device Identifier (DI) Information

Brand Name: Alloy Melter
Version or Model: MT803D
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MT803D
Company Name: MEDTEC, INC.

Primary DI Number: 00841439111710
Issuing Agency: GS1
Commercial Distribution End Date: July 10, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 103977526 *Terms of Use

Device Description: 12 Quart, 115v

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?
44357	Melting pot unit	A mains electricity (AC-powered) device designed for the melting and pouring/tapping of materials in a safe and controlled manner, e.g., paraffin wax for use in the laboratory for embedding tissue samples, Rose's metal for the production of beam blocks in radiotherapy departments. It consists of a heating element that can be of varying designs, e.g., hollow thermal heater, flat plate heater, and a pot/pitcher that may pour through an open top or have a tap at the bottom for the tapping of clean material avoiding residue that may have risen to the surface.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPY	Shield, protective, personnel

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 17.868 Inch
Width: 17.95 Inch

Device Record Status

Public Device Record Key: be967957-5c31-4afe-bc4d-07cc91a9a23e
Public Version Date: July 10, 2020
Public Version Number: 5
DI Record Publish Date: June 14, 2018

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: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(712)737-8688
Email: radiotherapy.complaints@civcort.com

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