Syntel Silicone Thrombectomy Catheter A4538

GUDID 00840663109784

Syntel Silicone Thrombectomy Catheter

Lemaitre Vascular, Inc.

Thrombectomy balloon catheter
Primary Device ID00840663109784
NIH Device Record Key813753ca-947a-42ed-b883-6dbe03374dfc
Commercial Distribution StatusIn Commercial Distribution
Brand NameSyntel Silicone Thrombectomy Catheter
Version Model NumberA4538
Catalog NumberA4538
Company DUNS184805166
Company NameLemaitre Vascular, 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com

Device Dimensions

Catheter Working Length80 Centimeter
Catheter Gauge3 French
Total Volume0.23 Milliliter
Catheter Working Length80 Centimeter
Catheter Gauge3 French
Total Volume0.23 Milliliter
Catheter Working Length80 Centimeter
Catheter Gauge3 French
Total Volume0.23 Milliliter
Catheter Working Length80 Centimeter
Catheter Gauge3 French
Total Volume0.23 Milliliter
Catheter Working Length80 Centimeter
Catheter Gauge3 French
Total Volume0.23 Milliliter
Catheter Working Length80 Centimeter
Catheter Gauge3 French
Total Volume0.23 Milliliter
Catheter Working Length80 Centimeter
Catheter Gauge3 French
Total Volume0.23 Milliliter
Catheter Working Length80 Centimeter
Catheter Gauge3 French
Total Volume0.23 Milliliter
Catheter Working Length80 Centimeter
Catheter Gauge3 French
Total Volume0.23 Milliliter
Catheter Working Length80 Centimeter
Catheter Gauge3 French
Total Volume0.23 Milliliter
Catheter Working Length80 Centimeter
Catheter Gauge3 French
Total Volume0.23 Milliliter
Catheter Working Length80 Centimeter
Catheter Gauge3 French
Total Volume0.23 Milliliter
Catheter Working Length80 Centimeter
Catheter Gauge3 French
Total Volume0.23 Milliliter
Catheter Working Length80 Centimeter
Catheter Gauge3 French
Total Volume0.23 Milliliter
Catheter Working Length80 Centimeter
Catheter Gauge3 French
Total Volume0.23 Milliliter
Catheter Working Length80 Centimeter
Catheter Gauge3 French
Total Volume0.23 Milliliter
Catheter Working Length80 Centimeter
Catheter Gauge3 French
Total Volume0.23 Milliliter
Catheter Working Length80 Centimeter
Catheter Gauge3 French
Total Volume0.23 Milliliter
Catheter Working Length80 Centimeter
Catheter Gauge3 French
Total Volume0.23 Milliliter
Catheter Working Length80 Centimeter
Catheter Gauge3 French
Total Volume0.23 Milliliter
Catheter Working Length80 Centimeter
Catheter Gauge3 French
Total Volume0.23 Milliliter
Catheter Working Length80 Centimeter
Catheter Gauge3 French
Total Volume0.23 Milliliter
Catheter Working Length80 Centimeter
Catheter Gauge3 French
Total Volume0.23 Milliliter
Catheter Working Length80 Centimeter
Catheter Gauge3 French
Total Volume0.23 Milliliter
Catheter Working Length80 Centimeter
Catheter Gauge3 French
Total Volume0.23 Milliliter
Catheter Working Length80 Centimeter
Catheter Gauge3 French
Total Volume0.23 Milliliter
Catheter Working Length80 Centimeter
Catheter Gauge3 French
Total Volume0.23 Milliliter
Catheter Working Length80 Centimeter
Catheter Gauge3 French
Total Volume0.23 Milliliter
Catheter Working Length80 Centimeter
Catheter Gauge3 French
Total Volume0.23 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100840663109784 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXECatheter, Embolectomy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-28
Device Publish Date2021-06-18

On-Brand Devices [Syntel Silicone Thrombectomy Catheter]

00840663109852Syntel Silicone Thrombectomy Catheter
00840663109845Syntel Silicone Thrombectomy Catheter
00840663109838Syntel Silicone Thrombectomy Catheter
00840663109821Syntel Silicone Thrombectomy Catheter
00840663109814Syntel Silicone Thrombectomy Catheter
00840663109807Syntel Silicone Thrombectomy Catheter
00840663109784Syntel Silicone Thrombectomy Catheter

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