AccessGUDID - DEVICE: WEB Aneurysm Embolization System (00856956005855)

GUDID

Device Identifier (DI) Information

Brand Name: WEB Aneurysm Embolization System
Version or Model: W2-9-5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FGA15090-050
Company Name: SEQUENT MEDICAL, INC.

Primary DI Number: 00856956005855
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 796807340 *Terms of Use

Device Description: WEB 27 SL 9x5

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":	Yes
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
OPR	Intrasaccular Flow Disruption Device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P170032	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: 9 x 5 mm

Device Record Status

Public Device Record Key: ca9e7891-11e5-48a3-ab9a-6e2cdfc480c0
Public Version Date: February 05, 2021
Public Version Number: 4
DI Record Publish Date: April 01, 2019