Strauss Surgical

Basic Information

• Brand Name: Strauss Surgical
• Primary DI: 00850033250053
• Version / Model: STS-URS-BIO-50-60F
• Company Name: AMERICAN MEDICAL ENDOSCOPY, INC.
• Labeler DUNS: 024725124
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-11
• Public Version: 1
• Public Version Date: 2021-10-19
• Public Version Status: New
• Public Device Record Key: 52d442dd-f026-41c3-bda8-aef9b2a5e0c3

Device Characteristics

• Single Use: No
• 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: 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
HAO	Instrument, Surgical, Non-Powered	Neurology	882.4535	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38810	Flexible endoscopic biopsy forceps, reusable	A flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy, laryngoscopy) for histopathological examination. It is typically a flexible metal coil with a pair of scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850033250053	GS1