AccessGUDID - DEVICE: Skin Flap Gauge 6 (09008737035433)

GUDID

Device Identifier (DI) Information

Brand Name: Skin Flap Gauge 6
Version or Model: 03543
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Primary DI Number: 09008737035433
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 300764032 *Terms of Use

Device Description: Reusable Surgical Tool

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?
64959	Skin flap thickness gauge	A hand-held manual surgical instrument intended to be used to evaluate the thickness of a skin flap to help determine its appropriate thickness prior to surgery (e.g., hearing implant surgery). It is in the form of a handle with a calibrated distal opening against which the skin flap is compared. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MCM	Implant, Cochlear

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P000025	014
P000025	021
P000025	050
P000025	070

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: bd4e14ec-a8ba-4593-b9e5-2ab8cc81c187
Public Version Date: July 22, 2022
Public Version Number: 5
DI Record Publish Date: September 23, 2014