AccessGUDID - DEVICE: Vent. Tube Tuebingen Type Gold-plated Ag (EHKM10150101)

GUDID

Device Identifier (DI) Information

Brand Name: Vent. Tube Tuebingen Type Gold-plated Ag
Version or Model: 1015010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1015010
Company Name: Heinz Kurz GmbH

Primary DI Number: EHKM10150101
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341155720 *Terms of Use

Device Description: Middle ear implantable mould

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?
31934	Middle ear moulding	A preformed device intended to be implanted to reconstruct the middle ear cavity during repair of the tympanic membrane by permitting an ample air-filled cavity to be maintained in the middle ear; it also promotes regeneration of the mucous membrane lining of the middle ear cavity. It is typically made of synthetic polymer materials [e.g., polyamide, polytetrafluoroethylene (PTFE), silicone elastomer or polyethylene (PE)].	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
ETD	Tube, Tympanostomy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K973226	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: fa3672b6-a14f-45e8-8d50-f75d718c9fab
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 21, 2015