AccessGUDID - DEVICE: WEB Detachment Controller (00856956005282)

GUDID

Device Identifier (DI) Information

Brand Name: WEB Detachment Controller
Version or Model: WDC-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FGA00175
Company Name: SEQUENT MEDICAL, INC.

Primary DI Number: 00856956005282
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 796807340 *Terms of Use

Device Description: WEB Detachment Controller

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
60637	Vascular implant detacher, electronic, single-use	A noninvasive, hand-held, electrically-powered unit intended to deliver a low-level electric current to break the connection between a vascular implantable device (typically a neurovascular or peripheral embolization coil or stent) and its deployment device (i.e., implant inserter or delivery wire) via an electrolytic reaction. It is intended to connect to the proximal end of an appropriate implant inserter (delivery wire) which conducts the current to the electrically-unstable detachment point. This is a single-use device.	Active	false

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
No Device Sizes

Device Record Status

Public Device Record Key: d9d013c6-b968-4bac-803e-31468d9ccbbe
Public Version Date: May 03, 2023
Public Version Number: 5
DI Record Publish Date: April 01, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10856956005289	5	00856956005282		In Commercial Distribution	Box of 5

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 949.830.9600
Email: customerserviceus@sequentmedical.com

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