Adelante S

Basic Information

• Brand Name: Adelante S
• Primary DI: 10885672104532
• Version / Model: ASU8513B5
• Catalog Number: ASU8513B5
• Company Name: Oscor Inc.
• Labeler DUNS: 101835833
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2017-11-16
• Public Version: 4
• Public Version Date: 2019-06-07
• Public Version Status: Update
• Public Device Record Key: 4d254f24-1572-4200-845c-9ba172610c83

Device Description

Peel-Away Introducer with Hemostatic Valve and Side Port, 8.5F

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: 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
DYB	INTRODUCER, CATHETER	Cardiovascular	870.1340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58865	Vascular catheter introduction set, nonimplantable	A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10885672104532	GS1
Unit of Use	00885672104535	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K073100	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Sheath Length 13 cm
Device Size Text, specify			Dilator Length 18 cm
Device Size Text, specify			Guidewire - Length: 50 cm, OD: 0.038 in
Lumen/Inner Diameter	2.9	Millimeter
Needle Gauge	18	Gauge
Device Size Text, specify			Syringe 10 cc

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius