AccessGUDID - DEVICE: Bead Block™ (00191506011369)

GUDID

Device Identifier (DI) Information

Brand Name: Bead Block™
Version or Model: EB2S507-US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EB2S507-US
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 00191506011369
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Bland Embolic Bead

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
60938	Embolization particle, non-bioabsorbable	A non-bioabsorbable, implantable bead/microsphere intended to be introduced into the peripheral vasculature during an interventional radiology procedure to treat hypervascularized tumours and arteriovenous malformation in a variety of anatomies (e.g., head, neck, spine, liver, genitourinary tract, uterus, gastrointestinal, limbs and lungs); it does not include a pharmaceutical agent. It is typically available as injectable solution containing numerous microspheres [e.g., compressible polyvinyl alcohol (PVA) microspheres] intended to permanently obstruct blood flow to the tumour/malformation.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NAJ	Agents, embolic, for treatment of uterine fibroids
HCG	DEVICE, NEUROVASCULAR EMBOLIZATION
NOY	Agents, embolic, for treatment of benign prostatic hyperplasia
KRD	Device, Vascular, for Promoting Embolization

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2f006926-6092-4e5a-936d-5d0614161c74
Public Version Date: October 22, 2021
Public Version Number: 1
DI Record Publish Date: October 14, 2021