AccessGUDID - DEVICE: VORP Sizer Kit (09008738500558)

GUDID

Device Identifier (DI) Information

Brand Name: VORP Sizer Kit
Version or Model: 50055
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Primary DI Number: 09008738500558
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 300764032 *Terms of Use

Device Description: Middle Ear Implant Template Kit

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):	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?
44069	ENT surgical procedure kit, non-medicated, single-use	A collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MPV	Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P990052	023

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Shall be stored at room temperature protected from moisture and direct heat.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7c3e6065-690f-493d-b56b-2e5618515961
Public Version Date: September 16, 2022
Public Version Number: 5
DI Record Publish Date: September 22, 2014