AccessGUDID - DEVICE: Dentus M2 Comfort (05414904038673)

GUDID

Device Identifier (DI) Information

Brand Name: Dentus M2 Comfort
Version or Model: DENTUS M2 Comfort 2x3cm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 34HOS
Company Name: AGFA

Primary DI Number: 05414904038673
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 374444883 *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?
40978	Dental x-ray film, non-screen	A non-screen x-ray film specifically sized and designed for use with dental x-ray systems. It is designed for direct exposure to x-rays and is relatively insensitive to the visible light emitted from screens. It is prepared as an emulsion of light and x-ray sensitive granules on one (single-emulsion film) or both (double-emulsion film) sides of a transparent film base made of cellulose acetate, polyester resin or other appropriate material.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IWZ	Film, radiographic

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
Special Storage Condition, Specify: Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment Temperature: between 4 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 2 Centimeter
Width: 3 Centimeter

Device Record Status

Public Device Record Key: 24e19c3f-da6b-46bc-923b-897fd807d421
Public Version Date: November 14, 2022
Public Version Number: 1
DI Record Publish Date: November 04, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
05414904236949	35	05414904038673		In Commercial Distribution

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 05414904236956 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(877)777-2432
Email: salesinfo@agfa.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES