AccessGUDID - DEVICE: Partial Middle Ear Implant (04250381804582)

GUDID

Device Identifier (DI) Information

Brand Name: Partial Middle Ear Implant
Version or Model: 12100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12100
Company Name: Spiggle & Theis Medizintechnik GmbH

Primary DI Number: 04250381804582
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 332893028 *Terms of Use

Device Description: Partial middle ear implant, shortenable, titanium, with head, 5.5x0.3 mm, sterile

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 [?]
K030492	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
Special Storage Condition, Specify: Storage must protect from dust, moisture and contamination. Avoid direct sunlight during storage.

Clinically Relevant Size

[?]

Size Type Text
Length: 5.5 Millimeter

Device Record Status

Public Device Record Key: e98e8cec-1165-40de-9f8d-ddf02f4fad25
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 04, 2015