AccessGUDID - DEVICE: TTP-Tuebingen Type BELL Partial Titanium (EHKM10022281)

GUDID

Device Identifier (DI) Information

Brand Name: TTP-Tuebingen Type BELL Partial Titanium
Version or Model: 1002228
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1002228
Company Name: Heinz Kurz GmbH

Primary DI Number: EHKM10022281
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341155720 *Terms of Use

Device Description: Ossicular Prosthesis, partial

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?
35690	Ossicular prosthesis, partial	A sterile device intended to be implanted for the functional reconstruction of segments of the ossicular chain (mallues, incus, and/or 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 metal [e.g., stainless steel, titanium (Ti)], polymers, or a combination of these materials.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
ETB	Prosthesis, Partial Ossicular Replacement

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K972492	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: f60dde49-b315-450b-bfdc-b5923f9f5d78
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 21, 2015