AccessGUDID - DEVICE: Otoferm® Creme (E2390561)

GUDID

Device Identifier (DI) Information

Brand Name: Otoferm® Creme
Version or Model: 056
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 056
Company Name: Dreve Otoplastik GmbH

Primary DI Number: E2390561
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315808340 *Terms of Use

Device Description: No.

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):	No
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?
58807	Moisture/lubrication otic solution	A solution intended to be applied to the external auditory canal of the ear, as a spray or as drops, to provide moisture and/or lubrication typically to facilitate softening and/or removal of ear wax, removal of impurities, barrier to external water, and/or loosening of encrustations. It may be an aqueous-based or oil-based solution and may include hydrogen peroxide, surfactants, and/or plant extracts; some of the ingredients may have a non-pharmaceutical antimicrobial and/or anti-inflammatory properties. It is normally available [non-prescription] over-the-counter (OTC). After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KMJ	Lubricant, patient

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
Storage 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: e46cefe1-8be2-442d-a2bf-8a922a098e7f
Public Version Date: January 20, 2025
Public Version Number: 4
DI Record Publish Date: August 12, 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
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: 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: +49230388070
Email: otoplastik@dreve.de

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