6F Wallaby Long Sheath

Primary DI
06970908211997
Brand
6F Wallaby Long Sheath
Company
Shanghai Wallaby Medical Technologies Co., Inc.
Model
SH6F100MP
Device description
The 6F Wallaby Long Sheath is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter.
Published
2023-04-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
QJPCatheter, Percutaneous, NeurovasculatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222603000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K2226030006F Wallaby Long SheathWallaby Medical, Inc.2023-03-02DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970908211997PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970908211997069709082119976970908211997

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
544535295
Device count
1
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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06970908212840Avenir10CSW020202025-01-15
06970908212857Avenir10CSW030202025-01-15
06970908212864Avenir10CSW030302025-01-15
06970908212871Avenir10CSW040302025-01-15
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