Embosphere®

GUDID 10884450089221

BIOSPHERE MEDICAL

Embolization particle, non-bioabsorbable

• Primary Device ID: 10884450089221
• NIH Device Record Key: 6555ffbd-ec00-441e-8dbd-0365b96e7ee5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Embosphere®
• Version Model Number: 00884450089224
• Company DUNS: 635091932
• Company Name: BIOSPHERE MEDICAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450089224 [Primary]
GS1	10884450089221 [Package]; Contains: 00884450089224; Package: [5 Units]; In Commercial Distribution

FDA Product Code

• NAJ: AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-10-30

On-Brand Devices [Embosphere®]

• 10884450403737: 00884450403730
• 10884450403461: 00884450403464
• 10884450403447: 00884450403440
• 10884450403171: 00884450403174
• 10884450116712: 00884450116715
• 10884450116293: 00884450116296
• 10884450115166: 00884450115169
• 10884450114220: 00884450114223
• 10884450110628: 00884450110621
• 10884450109851: 00884450109854
• 10884450109516: 00884450109519
• 10884450106058: 00884450106051
• 10884450104757: 00884450104750
• 10884450098568: 00884450098561
• 10884450098421: 00884450098424
• 10884450089337: 00884450089330
• 10884450089320: 00884450089323
• 10884450089313: 00884450089316
• 10884450089306: 00884450089309
• 10884450089290: 00884450089293
• 10884450089283: 00884450089286
• 10884450089276: 00884450089279
• 10884450089269: 00884450089262
• 10884450089252: 00884450089255
• 10884450089245: 00884450089248
• 10884450089238: 00884450089231
• 10884450089221: 00884450089224
• 10884450403201: 00884450403204
• 10884450403157: 00884450403150
• 10884450403430: 00884450403433
• 10884450403409: 00884450403402
• 10884450403928: 00884450403921
• 10884450403867: 00884450403860
• 10884450403553: 00884450403556
• 10884450403454: 00884450403457
• 10884450403423: 00884450403426
• 10884450403133: 00884450403136
• 10884450402945: 00884450402948
• 10884450403058: 00884450403051
• 10884450299439: 00884450299432
• 10884450403829: 00884450403822
• 10884450403713: 00884450403716