Dornier MedTech

Basic Information

• Brand Name: Dornier MedTech
• Primary DI: 00810116020676
• Version / Model: SLID3515S
• Catalog Number: 48012514
• Company Name: DORNIER MEDTECH AMERICA, INC.
• Labeler DUNS: 130789944
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-04
• Public Version: 3
• Public Version Date: 2020-01-29
• Public Version Status: Update
• Public Device Record Key: 7be42bbc-ec60-4ff3-a664-66ef3146f13a
• Distribution End Date: 2018-12-04

Device Description

Hydrophilic Nitinol Guidewire, 0.035" diameter, 150 cm length, 3 cm tip.

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
EYA	Stylet, Ureteral	Gastroenterology, Urology	876.5130	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46691	Gastro-urological guidewire, single-use	A sterile metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00810116020683	GS1	Box	5	Not in Commercial Distribution	2018-12-04
Primary	00810116020676	GS1