Ambler Surgical

Basic Information

• Brand Name: Ambler Surgical
• Primary DI: 00190660051822
• Version / Model: 30-205
• Catalog Number: 30-205
• Company Name: AMBLER SURGICAL CORP.
• Labeler DUNS: 015272206
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-29
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 10000490-4829-40b4-9696-045e0f22f009

Device Description

Duplay uterine tenaculum forceps, 10", curved shanks, curved jaws, 1x1 teeth, ring 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: No
• 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
HCZ	FORCEPS, SURGICAL, GYNECOLOGICAL	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35804	Uterine clamp	A scissors-like, hand-held manual surgical instrument designed to grasp and/or manipulate the uterus during surgery. It is typically made of high-grade stainless steel and will have wide, rounded, blades at the distal end to hold the uterus during a surgical intervention. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190660051822	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K092840	000