FDA.reportPublic FDA data

Super Distal Access (SDA)

Primary DI
00816900020075
Brand
Super Distal Access (SDA)
Company
Inneuroco, Inc.
Model
GEN-10820-115
Catalog number
GEN-10820-115
Device description
Catheter, Hemostasis Valve, & Introducer
Published
2017-11-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816900020075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816900020075008169000200758169000200750816900020075

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Lumen/Inner Diameter0
Outer Diameter0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep in cool, dark, dry place

Contacts#

Phone, Email table
PhoneEmail
(954) 742-5988Complaints@InNeuroCo.com

Regulatory Flags#

DUNS number
080407341
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816900020013Intermediate CatheterGEN-10815-115GEN-10815-1152017-11-08
00816900020020Intermediate CatheterGEN-10815-125GEN-10815-1252017-11-08
00816900020037Intermediate CatheterGEN-10815-105GEN-10815-1052017-11-08
00816900020082Super Distal Access (SDA)GEN-10820-125GEN-10820-1252017-11-08
00816900020099Super Distal Access (SDA)GEN-10820-135GEN-10820-1352017-11-08
00816900020259SYPHONTRAK SDAGEN-10820-115GEN-10820-1152017-11-08
00816900020266SYPHONTRAK SDAGEN-10820-125GEN-10820-1252017-11-08
00816900020273SYPHONTRAK SDAGEN-10820-135GEN-10820-1352017-11-08
00816900020310SYPHONTRAKGEN-10815-105GEN-10815-1052017-11-08
00816900020327SYPHONTRAKGEN-10815-115GEN-10815-1152017-11-08
00816900020334SYPHONTRAKGEN-10815-125GEN-10815-1252017-11-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450416723SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450422755SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450423110SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450427170SureCrossMerit Medical Systems, Inc.DQY2026-09-22
10886704074892ENVOYCerenovus, Inc.DQY2026-09-19
10841156108267TRAPLINERTELEFLEX INCORPORATEDDQY2026-08-18
00199150070114NAMEDTRONIC, INC.DQY2026-04-13
00199150070121NAMEDTRONIC, INC.DQY2026-04-13
00199150070138NAMEDTRONIC, INC.DQY2026-04-13
00199150070145NAMEDTRONIC, INC.DQY2026-04-13
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQY2026-02-24
08718122013984Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122028896Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122013915Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
10841156111878TURNPIKETELEFLEX INCORPORATEDDQY2025-09-09
10841156111250GUIDELINERTELEFLEX INCORPORATEDDQY2025-07-14
00195451000836Shockwave CS Guide CatheterShockwave Medical, Inc.DQY2025-06-02
10801902217773ARROWTELEFLEX INCORPORATEDDQY2024-04-08
10801902217988ARROWTELEFLEX INCORPORATEDDQY2024-03-18
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