NA

Basic Information

• Brand Name: NA
• Primary DI: 04055207001028
• Version / Model: 8307502
• Catalog Number: 8307502
• Company Name: Richard Wolf GmbH
• Labeler DUNS: 315304071
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-27
• Public Version: 6
• Public Version Date: 2019-05-10
• Public Version Status: Update
• Public Device Record Key: 7f31a4bc-e5f5-4c96-9865-f4e796d68555

Device Description

TISSUE SEAL BLACK Ø 12/15MM reusable

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• 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: ["Ethylene Oxide", "Moist Heat or Steam Sterilization", "Hydrogen Peroxide"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HET	LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)	Obstetrics/Gynecology	884.1720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37871	Crown surgical drill bit, reusable	A shaft of metal with a hollow centre designed for overdrilling a surgical screw or screw shaft to expose it for its removal, with another instrument, when the screw head has become defective or detached. The device is commonly called a "hollow mill" or "crown drill", but may also be referred to as a "hollow reamer", and is designed as a cylindrical hollow shell with a thin wall that has saw teeth at the cutting edge. It is inserted into a surgical power tool for rotation. This device may also be used to obtain core bone biopsies. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04055207001028	GS1
Unit of Use	04055207059548	GS1

Customer Contacts

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