AccessGUDID - DEVICE: WiscMed (00850009819017)

GUDID

Device Identifier (DI) Information

Brand Name: WiscMed
Version or Model: spec1-300
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WISC MED, LLC

Primary DI Number: 00850009819017
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070666290 *Terms of Use

Device Description: A single use, plastic, rigid, cone shaped, speculum designed specifically for use with the WiscMed Wispr digital otoscope. This item number consists of a quantity of 300 specula, packaged in plastic sleeves designed to fit traditional wall mounted specula holders found in most patient exam rooms.

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):	No
Over the Counter (OTC):	Yes
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?
34897	Ear speculum, single-use	A semi-rigid or rigid, plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may be referred to as an ear cannula. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EPY	Speculum, Ent

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: c421f9cd-5c54-4b38-9d91-c80934a84690
Public Version Date: April 06, 2020
Public Version Number: 1
DI Record Publish Date: March 27, 2020