Ambler Surgical

Basic Information

• Brand Name: Ambler Surgical
• Primary DI: 00190660205003
• Version / Model: Optical foreign body forceps
• Catalog Number: 96-775
• Company Name: AMBLER SURGICAL CORP.
• Labeler DUNS: 015272206
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-07
• Public Version: 1
• Public Version Date: 2021-01-15
• Public Version Status: New
• Public Device Record Key: 70cbc111-9eff-4dc9-900f-c15a43288678

Device Description

Optical foreign body forceps, 5.5mm diameter, 540.0mm working length, spring action handle, for use with bronchoscope size 8.50 up to 7.50mm

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: No
• 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
KAE	FORCEPS, ENT	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35802	Otologic clamp	A hand-held manual surgical instrument designed to grasp internal ear structures (e.g., a bone of the ossicles) during an ear/nose/throat (ENT) procedure. It typically has a self-retaining, scissors-like design with ring handles and is made of high-grade stainless steel. It is available in various sizes and blade designs that may utilize carbide inserts. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190660205003	GS1

Customer Contacts

• Phone: [phone] ext. 0
• Email: [email protected]