GRAFTSITE

Basic Information

• Brand Name: GRAFTSITE
• Primary DI: 15060238201145
• Version / Model: D201045
• Company Name: SUMMIT MEDICAL LIMITED
• Labeler DUNS: 221751311
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-21
• Public Version: 3
• Public Version Date: 2019-07-04
• Public Version Status: Update
• Public Device Record Key: 96c1922c-0c46-4a83-a55d-91173368d5ba

Device Description

GRAFTSITE Delivery Assistance Device

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: No
• 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
CAZ	Anesthesia Conduction Kit	Anesthesiology	868.5140	2
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	868.5150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35795	Anaesthesia conduction catheter	A flexible tube intended to be percutaneously introduced for the repeated or continuous injection of local anaesthetics for preoperative, intraoperative, or postoperative regional anaesthesia and/or pain management; it may be placed in the epidural space, into or around surgical wound sites, and near peripheral nerves. It may include devices dedicated to catheter introduction/function (e.g., needle, sheath); it is not coated with an antimicrobial agent. This device is typically used during surgical or diagnostic procedures or for the temporary relief of chronic pain in the limbs, pelvis, abdomen, or lumbar spine. This is a single-use device intended to be used in a sterile condition.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15060238201145	GS1
Package	25060238201142	GS1	Cardboard Carton	5	In Commercial Distribution
Package	35060238201149	GS1	Box	25	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K173110	000