Instrapac

Basic Information

• Brand Name: Instrapac
• Primary DI: 05010058070691
• Version / Model: 7069
• Catalog Number: 7069
• Company Name: ROBINSON HEALTHCARE LIMITED
• Labeler DUNS: 237799775
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-12
• Public Version: 1
• Public Version Date: 2022-08-22
• Public Version Status: New
• Public Device Record Key: a107c0a7-3fbc-489d-a81a-342a109483b8

Device Description

Instrapac Trousseau Bowlby Tracheal Dilating Forceps 14cm/5.5in X 50

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: No
• 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
KAE	FORCEPS, ENT	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63973	Tracheal surgery dilator, single-use	A sterile, hand-held, manual surgical instrument intended to be used during surgical intervention of the trachea to dilate tracheal structures/passages, typically during the creation of a tracheostoma and/or for expanding the margins of a tracheostoma to assist in the insertion of a tracheostomy tube. It may be in the form of a slender hollow or solid cylinder or a scissors-like instrument. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05010058170698	GS1	Box	50	In Commercial Distribution
Primary	05010058070691	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	14	Centimeter

Storage Conditions

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