AccessGUDID - DEVICE: Implant Template, single-use, for the SONATATi100 (09008737038755)

GUDID

Device Identifier (DI) Information

Brand Name: Implant Template, single-use, for the SONATATi100
Version or Model: 03875
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Primary DI Number: 09008737038755
Issuing Agency: GS1
Commercial Distribution End Date: May 02, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 300764032 *Terms of Use

Device Description: Single-Use Surgical Tool

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?
58804	Surgical implant template, single-use	A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MCM	Implant, Cochlear

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P000025	021
P000025	042
P000025	054

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: The sterilised content may only be stored in this sterile packaging inside the Surgical Accessory Box at toom temperautre until the stated expiry date.
Handling Environment Temperature: between -4 and 131 Degrees Fahrenheit
Handling Environment Temperature: between -20 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9f90cd56-a7f4-42d0-bc06-0155b0152e25
Public Version Date: May 07, 2024
Public Version Number: 6
DI Record Publish Date: September 23, 2014