AccessGUDID - DEVICE: Fisch cutting and preparation jig (04250676732354)

GUDID

Device Identifier (DI) Information

Brand Name: Fisch cutting and preparation jig
Version or Model: 10-738-06
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-738-06
Company Name: Spiggle & Theis Medizintechnik GmbH

Primary DI Number: 04250676732354
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 332893028 *Terms of Use

Device Description: for stapes prostheses with PTFE base 0.6 mm

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":	Yes
For Single-Use:	No
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?
58387	Surgical cutting/shaping board, reusable	A stiff, plastic device intended to be used as a surface to trim/contour objects or tissues (e.g., implants, transplants) in an operating room (OR) or other clean room during a surgical procedure. It may be flat or contoured and/or have measurement graduations as a visual approximation aid. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NNR	BLOCK, CUTTING, ENT, NON-STERILE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: a0163e06-0108-4823-accd-75525886b30f
Public Version Date: November 09, 2022
Public Version Number: 3
DI Record Publish Date: September 14, 2022