Fisch cutting and preparation jig

Basic Information

• Brand Name: Fisch cutting and preparation jig
• Primary DI: 04250676732354
• Version / Model: 10-738-06
• Catalog Number: 10-738-06
• Company Name: Spiggle & Theis Medizintechnik GmbH
• Labeler DUNS: 332893028
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-14
• Public Version: 3
• Public Version Date: 2022-11-09
• Public Version Status: Update
• Public Device Record Key: a0163e06-0108-4823-accd-75525886b30f

Device Description

for stapes prostheses with PTFE base 0.6 mm

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NNR	BLOCK, CUTTING, ENT, NON-STERILE	Ear, Nose, Throat	874.3540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04250676732354	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]