AccessGUDID - DEVICE: Optima Coil System (00818053021473)

GUDID

Device Identifier (DI) Information

Brand Name: Optima Coil System
Version or Model: OPTI0206CSS10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N/A
Company Name: BALT USA LLC

Primary DI Number: 00818053021473
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 945543689 *Terms of Use

Device Description: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations (AVMs) and arteriovenous fistulae. The Optima Coil System is also indicated for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolization in the peripheral vasculature. The Optima Coil System comprises of implant coil and a pusher assembly. The Optima Coil System is designed fr use with the XCEL Detachment Controller. The Optima coil is detached thermally with the XCEL Detachment Controller.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60940	Neurovascular embolization coil	A non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HCG	Device, Neurovascular Embolization

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172390	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store at a controlled room temperature in a dry place.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Complex-10 SuperSoft 2mm x 6cm

Device Record Status

Public Device Record Key: 28d29d8b-8a60-4822-bf50-1ed05a0c0f7d
Public Version Date: February 05, 2021
Public Version Number: 2
DI Record Publish Date: September 01, 2018