AccessGUDID - DEVICE: Sanibel Supply A/S (05711117244335)

GUDID

Device Identifier (DI) Information

Brand Name: Sanibel Supply A/S
Version or Model: Sanibel REM Probe Tubes, type A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Interacoustics A/S

Primary DI Number: 05711117244335
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 306308354 *Terms of Use

Device Description: Black, sample kit. Accessory for Real Ear Measurement (REM)

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":	Yes
For Single-Use:	Yes
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?
66691	Audiometric/hearing aid tester support kit	A collection of devices and supplies designed to facilitate the use of an audiometric/hearing aid tester that typically includes two or more of the following: a real-ear probe tube, ear tips and cleaning wipes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ETW	Calibrator, Hearing Aid / Earphone And Analysis Systems

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: ec976018-98d5-46a6-84df-0a2c5a52226e
Public Version Date: October 15, 2024
Public Version Number: 1
DI Record Publish Date: October 07, 2024