INTELIJET

Basic Information

• Brand Name: INTELIJET
• Primary DI: 23596010129998
• Version / Model: 4536
• Catalog Number: 4536
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2015-09-23
• Public Version: 7
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: cd9cedfb-bd94-4bb1-8819-4a6ba29f4204

Device Description

INTELIJET FLUID SEALS, PACKAGE OF 25

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
NBH	ACCESSORIES,ARTHROSCOPIC	Orthopedic	888.1100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44806	Surgical instrument seal/seal maintenance set	A seal/collection of seals (e.g., O-rings, shaped or viscous gaskets) intended to be used to replace a damaged sealing component in the maintenance of certain endoscopes, microscopes, injectors, or other surgical instruments. It may include supportive hand tools (screwdrivers). It is not a laparoscopic access cannula seal.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	23596010129998	GS1
Unit of Use	03596010129994	GS1

Customer Contacts

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