PremierPro

Basic Information

• Brand Name: PremierPro
• Primary DI: 00818566017529
• Version / Model: 3601
• Catalog Number: 3601
• Company Name: SVS LLC
• Labeler DUNS: 831375089
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-04
• Public Version: 1
• Public Version Date: 2020-08-12
• Public Version Status: New
• Public Device Record Key: 62d902a4-d96e-4a39-9221-13c6b10f479a

Device Description

Amniotic Hook, Sterile

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
HHF	Remover, Intrauterine Device, Contraceptive, Hook-Type	Obstetrics/Gynecology	884.4530	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64027	Intrauterine device removal hook, single-use	A sterile, hand-held manual instrument intended to be used by a physician for the extraction of an intrauterine device (IUD). The proximal end forms a handle which may vary in shape and which tapers toward the distal end to form a hook. It is typically made of high-grade stainless steel. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10818566017526	GS1	box	100	In Commercial Distribution
Primary	00818566017529	GS1
Package	20818566017523	GS1	case	6	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]