AccessGUDID - DEVICE: Dispersalloy® Dispersed Phase Alloy Self-Activating Capsules (D00265628611)

GUDID

Device Identifier (DI) Information

Brand Name: Dispersalloy® Dispersed Phase Alloy Self-Activating Capsules
Version or Model: 656-2861
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 656-2861
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D00265628611
Issuing Agency: HIBCC
Commercial Distribution End Date: June 05, 2024
Device Count: 50
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Dispersed Phase Alloy, Fast Set, 1 Spill, 500 (400mg) Green caps

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?
34837	Transabdominal amnioscope	An endoscope with a rigid inserted portion intended for the visual examination of the foetus while in the amnion (the thin, tough membrane that lines the chorion and contains the foetus and the amniotic fluid). It is inserted into the body through an artificial orifice created by an incision made in the maternal abdominal wall through to the amniotic cavity. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This device is typically used to examine the foetus for external malformations, to obtain foetal blood or tissue samples, and for the observation of the colour and volume of amniotic fluid. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJJ	Alloy, amalgam

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: Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry.

Clinically Relevant Size

[?]

Size Type Text
Weight: 400 Milligram
Device Size Text, specify: Fast Set, 1 Spill, 10 cartons of 50 (400mg) Green caps

Device Record Status

Public Device Record Key: a7a1823c-fd1e-4059-be33-63280b59d6a8
Public Version Date: June 06, 2024
Public Version Number: 3
DI Record Publish Date: September 21, 2016