Black & Black Surgical

Basic Information

• Brand Name: Black & Black Surgical
• Primary DI: 00840329829445
• Version / Model: B95850
• Catalog Number: B95850
• Company Name: BLACK & BLACK SURGICAL, INC.
• Labeler DUNS: 004382282
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-10
• Public Version: 1
• Public Version Date: 2023-05-18
• Public Version Status: New
• Public Device Record Key: e78ff634-d2c3-4796-955f-9e762cf0aa06

Device Description

PRATT UTER DILATOR DE 29-31FR

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: 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: No
• 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
GCC	Dilator, catheter	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13643	Urethral sound, reusable	A hand-held manual surgical instrument designed to explore and measure the urethra. It is a slender hollow or solid cylindrical instrument made of metal or plastic typically with graduations of length displayed along its working end. It is typically available in a range of sizes and flexibilities. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840329829445	GS1

Customer Contacts

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