AccessGUDID - DEVICE: otosil IS-2 (EPRCA0010200)

GUDID

Device Identifier (DI) Information

Brand Name: otosil IS-2
Version or Model: 8 double cartridges of 2 x 25 ml
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A0010200
Company Name: pro3dure medical GmbH

Primary DI Number: EPRCA0010200
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312947842 *Terms of Use

Device Description: IS-2 - 8 double cartridges of 2 x 25 ml ocean-blue / white-opaque

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?
44974	Earmould impression material	A rubber-like material used to replicate the shape of an individual's ear canal for the manufacture of custom-made hearing aids and earmoulds. The device may be supplied as a two-component silicone (base and catalyst) which produces the usable product. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LDG	Kit, Earmold, Impression

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
Handling Environment Temperature: between 18 and 28 Degrees Celsius
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 96042319-6820-4c07-9f53-567051c02fdb
Public Version Date: October 26, 2023
Public Version Number: 1
DI Record Publish Date: October 18, 2023