SCI04526-01

GUDID 10888551040372

BALLOON INFLATION DEVICE ENCORE 26

STERILMED, INC.

Catheter/overtube balloon inflator, reprocessed
Primary Device ID10888551040372
NIH Device Record Key054a8786-2bd1-4217-bf86-5ed3aa009c7c
Commercial Distribution Discontinuation2019-04-17
Commercial Distribution StatusNot in Commercial Distribution
Version Model NumberSCI04526-01
Catalog NumberSCI04526-01
Company DUNS175899459
Company NameSTERILMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)541-0078
Emailcustomerservice@sterilmed.com
Phone+1(888)541-0078
Emailcustomerservice@sterilmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110888551040372 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKUINJECTOR AND SYRINGE, ANGIOGRAPHIC, BALLOON INFLATION, REPROCESSED

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10888551040372]

Ethylene Oxide


[10888551040372]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-05-06
Device Publish Date2016-09-22

Devices Manufactured by STERILMED, INC.

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10888551045186 - NA2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, D CURVE
10888551045193 - NA2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, F CURVE
10888551045209 - NA2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, D CURVE
10888551010313 - NA2021-01-22 KNIFE SET ECTRA II (PACK OF 3)
10888551021531 - NA2021-01-22 KNIVES (1) HOOK BLADE (1) TRIANGLE BLADE ENDOTRAC BLADE SYSTEM
10888551000048 - NA2020-11-06 CTS RELIEF KIT, 5PC SET
10888551012928 - NA2020-10-19 ENDO LUNG

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