AccessGUDID - DEVICE: Natus (05713315005992)

GUDID

Device Identifier (DI) Information

Brand Name: Natus
Version or Model: 8-61-20100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8-61-20100
Company Name: Natus Medical Denmark ApS

Primary DI Number: 05713315005992
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 306633756 *Terms of Use

Device Description: 1093, DESKTOP CRADLE, ACCESSORY

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?
63263	Auditory canal scanner	An electrically-powered device intended to collect data for the creation of three-dimensional (3-D) models of the auditory canal (outer ear). It consists of a short tube for insertion into the auditory canal, a display screen to assist operation of the device, and connections to a computing device for power and data transfer. It has no therapeutic nor diagnostic functions and may be used in a non-clinical setting by a trained professional.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ERA	Otoscope

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b5e3dee0-9cf4-43af-b5bb-8c9ccc5cb546
Public Version Date: October 30, 2025
Public Version Number: 5
DI Record Publish Date: September 14, 2020

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: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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