AccessGUDID - DEVICE: PERMITE (DO3640221012)

GUDID

Device Identifier (DI) Information

Brand Name: PERMITE
Version or Model: PERMITE 2SP ECT 500
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4022101
Company Name: SDI LIMITED

Primary DI Number: DO3640221012
Issuing Agency: HIBCC
Commercial Distribution End Date: January 12, 2025
Device Count: 500
Labeler D-U-N-S® Number*: 753221852 *Terms of Use

Device Description: No description.

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?
34836	Dental amalgam alloy	A composite of metals in fine particles, consisting mainly of silver (Ag), tin (Sn) and small amounts of copper (Cu), that is intended for mixing with mercury (Hg) to produce dental amalgam. Amalgam is a dental restorative material used to fill tooth cavities. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJJ	Alloy, amalgam

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K801639	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
Handling Environment Atmospheric Pressure: less than 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0b157fc9-dce0-4566-ba59-7113cbcb71e9
Public Version Date: January 13, 2025
Public Version Number: 4
DI Record Publish Date: September 23, 2016