FDA.report

RAIN Sheath® Tibial Pedal Introducer

Primary DI
20705032000106
Brand
RAIN Sheath® Tibial Pedal Introducer
Company
CORDIS CORPORATION
Model
TP506510N
Catalog number
TP506510N
Device description
RAIN Sheath® Tibial Pedal Introducer, 5F 10cm, Nitinol Wire Kit, 21G bare Needle
Published
2023-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
DYBIntroducer, catheter

Product Code Classifications

CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20705032000106PackageGS15In Commercial Distribution
10705032000109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2070503200010620705032000106
1070503200010910705032000109

GMDN Terms

TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
806136177
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
false
Sterilization required before use
false

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