ANGIO-SEAL

Basic Information

• Brand Name: ANGIO-SEAL
• Primary DI: 00389701011868
• Version / Model: 610119
• Catalog Number: 610119
• Company Name: TERUMO MEDICAL CORPORATION
• Labeler DUNS: 962520628
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-20
• Public Version: 7
• Public Version Date: 2022-03-21
• Public Version Status: Update
• Public Device Record Key: b64034db-1c11-48ba-8f8c-ecfaf8e8f0e6
• Distribution End Date: 2020-12-31

Device Description

ANGIO-SEAL STS Plus Vascular Closure 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: Yes
• MRI Safety: MR Safe
• 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
MGB	Device, hemostasis, vascular	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
60710	Femoral artery closure plug/patch, collagen	An implantable, bioabsorbable device designed for haemostasis/closure of a puncture site, through pressure/compression, on a patient having undergone femoral artery catheterization; it is intended as an alternative to manual compression or surgical techniques to reduce the time to haemostasis. It consists of an animal-derived collagen plug that is implanted using an included delivery device (e.g., guidewire, hand-held delivery unit) onto the extravascular surface of the femoral artery access site (top of arteriotomy site), and may be held in place with an included synthetic, bioabsorbable patch/anchor/suture to achieve haemostasis.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30389701011869	GS1	Shelfbox	5	Not in Commercial Distribution	2020-12-31
Primary	00389701011868	GS1
Package	50389701011863	GS1	Carton	2	Not in Commercial Distribution	2020-12-31

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	6	French

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black.
• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius