Leeches USA

Basic Information

• Brand Name: Leeches USA
• Primary DI: 00861028000300
• Version / Model: LE2000
• Company Name: LEECHES USA LTD
• Labeler DUNS: 603572942
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-08
• Public Version: 1
• Public Version Date: 2020-05-18
• Public Version Status: New
• Public Device Record Key: f5e5d0da-a621-44b6-9311-4db9f71e04b5

Device Description

Hirudo Medicinalis Leeches

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: 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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NRN	Leeches, Medicinal	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
64857	Medical leech	A medicinal leech intended to facilitate wound healing at sites complicated by blood pooling resulting from venous congestion, typically surgical transplants (e.g., finger transplants, skin grafts), by the slow, localized and controlled draining of blood naturally performed by leeches. Leech saliva has anticoagulant and anti-inflammatory properties to facilitate the therapy. Leech species are bred, processed and maintained to be used as medical devices. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00861028000300	GS1