BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

Hayden Medical

DI: 00840319734780 · Model: LL1507 · Hayden Medical, Inc.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: Hayden Medical
Primary DI: 00840319734780
Version / Model: LL1507
Catalog Number: LL1507
Company Name: Hayden Medical, Inc.
Labeler DUNS: 618214410
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2022-09-20
Public Version: 3
Public Version Date: 2023-08-03
Public Version Status: Update
Public Device Record Key: 97e15872-96e0-417b-a6bc-c146137420ff
Distribution End Date: 2023-08-03

Device Description

LLETZ Loop Electrode 15mm x 7mm radius 5" (13cm), sterile disposable, box of 5

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
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: Yes
PM Exempt: No
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
GEI	Electrosurgical, cutting & coagulation & accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61874	Open-surgery electrosurgical electrode, monopolar, single-use	An invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840319734780	GS1

Customer Contacts

Phone: +1(661)296-7200
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K091672	000