AccessGUDID - DEVICE: TTP-VARIO AERIAL Total Titanium (EHKM10040101)

GUDID

Device Identifier (DI) Information

Brand Name: TTP-VARIO AERIAL Total Titanium
Version or Model: 1004010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1004010
Company Name: Heinz Kurz GmbH

Primary DI Number: EHKM10040101
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341155720 *Terms of Use

Device Description: Ossicular Prosthesis, total

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
35674	Ossicular prosthesis, total	A sterile device intended to be implanted for the total functional reconstruction of the ossicular chain (mallues, incus, and stapes bones) to facilitate the conduction of sound waves from the tympanic membrane to the inner ear. It is designed to treat conductive hearing loss from traumatic or surgical injury, otosclerosis, congenital fixation of the stapes, or chronic middle ear disease. The device is typically in the form of a tube made of polymers.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
ETA	Replacement, Ossicular Prosthesis, Total

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K990923	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 598d442c-faf9-4056-a5b1-6fab1b48cdb8
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 21, 2015