Instrapac

Basic Information

• Brand Name: Instrapac
• Primary DI: 05010058083141
• Version / Model: 8314
• Catalog Number: 8314
• Company Name: ROBINSON HEALTHCARE LIMITED
• Labeler DUNS: 237799775
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-23
• Public Version: 2
• Public Version Date: 2026-02-12
• Public Version Status: Update
• Public Device Record Key: 98c63480-74db-4083-941e-1a59f95310af

Device Description

Instrapac Durbin IUD Pack with Speculum (Medium) X 20

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
OKV	Obstetrical Kit	Obstetrics/Gynecology	884.4520	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60644	Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use	A collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05010058183148	GS1	Box	20	In Commercial Distribution
Primary	05010058083141	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry and keep out of sunlight