SCI04526-01

GUDID 10888551040372

BALLOON INFLATION DEVICE ENCORE 26

STERILMED, INC.

Catheter/overtube balloon inflator, reprocessed

• Primary Device ID: 10888551040372
• NIH Device Record Key: 054a8786-2bd1-4217-bf86-5ed3aa009c7c
• Commercial Distribution Discontinuation: 2019-04-17
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: SCI04526-01
• Catalog Number: SCI04526-01
• Company DUNS: 175899459
• Company Name: STERILMED, INC.
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)541-0078
• Email: customerservice@sterilmed.com
• Phone: +1(888)541-0078
• Email: customerservice@sterilmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888551040372 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053188

FDA Product Code

• NKU: INJECTOR AND SYRINGE, ANGIOGRAPHIC, BALLOON INFLATION, REPROCESSED

Sterilization

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

[10888551040372]

Ethylene Oxide

[10888551040372]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-09-22

Devices Manufactured by STERILMED, INC.

• 10888551045179 - NA: 2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, F CURVE
• 10888551045186 - NA: 2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, D CURVE
• 10888551045193 - NA: 2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, F CURVE
• 10888551045209 - NA: 2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, D CURVE
• 10888551010313 - NA: 2021-01-22 KNIFE SET ECTRA II (PACK OF 3)
• 10888551021531 - NA: 2021-01-22 KNIVES (1) HOOK BLADE (1) TRIANGLE BLADE ENDOTRAC BLADE SYSTEM
• 10888551000048 - NA: 2020-11-06 CTS RELIEF KIT, 5PC SET
• 10888551012928 - NA: 2020-10-19 ENDO LUNG