Ambler Surgical

Basic Information

• Brand Name: Ambler Surgical
• Primary DI: 00190660121471
• Version / Model: Paparella-Saunders needle
• Catalog Number: 57-405
• 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: 4d99879c-ff04-45ae-9b09-ada40fb3bd36

Device Description

Paparella-Saunders needle, 6 1/2'', straight shaft, straight, heavy pointed tip, hexagonal handle

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
KBR	NEEDLE, TONSIL SUTURING	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37463	Exploratory blunt needle, reusable	A slender hand-held manual instrument designed with a dull curved tip intended to prevent damage to sensitive and delicate tissues while it is being used to explore within the body. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190660121471	GS1

Customer Contacts

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