GuideBlade

Basic Information

• Brand Name: GuideBlade
• Primary DI: 00860000561907
• Version / Model: AMB 1746
• Catalog Number: AMB 1746-10
• Company Name: Ambitus Medical Supplies LLC
• Labeler DUNS: 117065827
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2023-07-06
• Public Version: 1
• Public Version Date: 2023-07-14
• Public Version Status: New
• Public Device Record Key: 27150405-5136-46cd-a5fa-08a850a803bf

Device Description

Sterile GuideBlade

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GDX	Scalpel, One-Piece	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47569	Scalpel, single-use	A hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860000561907	GS1
Unit of Use	10860000561904	GS1
Package	20860000561901	GS1	Inner Carton	25	In Commercial Distribution
Package	30860000561908	GS1	Case	2	In Commercial Distribution

Customer Contacts

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