Amplatz Super Stiff

Basic Information

• Brand Name: Amplatz Super Stiff
• Primary DI: 08714729301929
• Version / Model: M00550090
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Labeler DUNS: 021717889
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2020-07-02
• Public Version Status: Update
• Public Device Record Key: bc7446de-af1f-46d0-96d5-e2fac77050e3

Device Description

Guidewire

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: 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
OCY	Endoscopic guidewire, gastroenterology-urology	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64109	Tracheobronchial guidewire	A sterile metal wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., bronchoscope, catheter] exclusively within the tracheobronchial tree. 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
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
Primary	08714729301929	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			0.038 in Diameter
Device Size Text, specify			260 cm Length
Device Size Text, specify			0.97 mm Diameter