NEEDLE

Basic Information

• Brand Name: NEEDLE
• Primary DI: B974HRP100C0
• Version / Model: HOUSE ROSEN NEEDLE
• Catalog Number: HRP100C
• Company Name: DR.FRIGZ INTERNATIONAL(PVT)LTD,
• Labeler DUNS: 645680125
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-21
• Public Version: 1
• Public Version Date: 2022-11-29
• Public Version Status: New
• Public Device Record Key: 9a794a5f-4ca0-4a3a-aee2-11e3d90dfeb4

Device Description

HOUSE ROSEN NEEDLE SLIGHTLY CVD OVER ALL LENGTH 6-1/2 INCH 16.5 CM (REGULAR TIP)

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: 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: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KAD	Elevator, Ent	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61143	Suturing needle, single-use	A cylindrical-shaped, solid, metal instrument intended to be used to insert and pull suture material through tissue (e.g., skin, fascia, serous, vascular, or other tissue/organ) during surgical stitching of tissues. It is available in various lengths, curvatures, diameters, cross-sectional shapes, and distal end forms. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B974HRP100C0	HIBCC

Device Sizes

Type	Value	Unit	Text
Length	6.5	Inch