ELMED

Basic Information

• Brand Name: ELMED
• Primary DI: 00842180175822
• Version / Model: T9909 FS-ST
• Catalog Number: T9909 FS-ST
• Company Name: ELMED INCORPORATED
• Labeler DUNS: 049290364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-11
• Public Version: 1
• Public Version Date: 2023-08-21
• Public Version Status: New
• Public Device Record Key: 1b4e24d5-de58-4cdb-a58d-a277d8f4522f

Device Description

FIBER OPTIC RETRACTOR W/ SUCTION; TEBBET STYLE, 1.25" x 3-1/4"

Device Characteristics

• Single Use: No
• 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: No
• PM Exempt: Yes
• 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: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAD	Retractor	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45918	Hand-held surgical retractor, reusable	A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.	No	Active
46678	Flexible endoscopic biopsy handpiece/needle	A sterile flexible device intended to be used to obtain tissue specimens, for histopathological examination, during various endoscopic procedures (e.g., bronchoscopy, gastroscopy). It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a biopsy needle which is operated by a control handle attached at the proximal end of the instrument. It is introduced into the body cavity through an artificial orifice of the body or the working channel of the compatible endoscope. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842180175822	GS1

Customer Contacts

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