AccessGUDID - DEVICE: WEB Aneurysm Embolization System (00854111006037)

GUDID

Device Identifier (DI) Information

Brand Name: WEB Aneurysm Embolization System
Version or Model: W4-7-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FGA25070-001
Company Name: SEQUENT MEDICAL, INC.

Primary DI Number: 00854111006037
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 796807340 *Terms of Use

Device Description: WEB 21 SLS 7

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: 7 x 5.6 mm

Device Record Status

Public Device Record Key: e74f4430-db76-4ca0-a85a-bb1a0b8204d9
Public Version Date: February 05, 2021
Public Version Number: 4
DI Record Publish Date: April 01, 2019