FDA.reportPublic FDA data

Valve Assist Blade, Reusable, Stainless Steel, 15mm x 26mm

Primary DI
00899054002678
Brand
Valve Assist Blade, Reusable, Stainless Steel, 15mm x 26mm
Company
KDL MEDICAL, INC.
Model
RAA-91526
Device description
Valve Assist Blade, Reusable, Stainless Steel, 15mm x 26mm
Published
2025-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFORetractor, Self-Retaining

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFORetractor, Self-RetainingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00899054002678PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00899054002678008990540026788990540026780899054002678

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, reusableA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
972-783-7005regulatory@chasemedical.com

Regulatory Flags#

DUNS number
791048924
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00899054002821Heart Assist, Single Use, 2 Finger Short, Malleable 36mm W X 54mm LHAF-2SHS2025-02-10
00899054002838Heart Assist, Single Use, 2 Finger Long, Malleable 36mm W X 90mm LHAF-2LGS2025-02-10
00899054002845Heart Assist, Single Use, 3 Finger Short, Malleable 60mm W X 54mm LHAF-3SHS2025-02-10
00899054002852Heart Assist, Single Use, 3 Finger Long, Malleable 60mm W X 90mm LHAF-3LGS2025-02-10
00899054002647Cobra Surgical Arm, 16cm Length, Lg/Med/Sm Links, Shaft ConnectRSA-90162025-02-10
00899054002654Cobra Surgical Arm, 19cm Length, Lg/Med/Sm Links, Shaft ConnectRSA-90192025-02-10
00899054002661Valve Assist Blade, Reusable, Stainless Steel, 11mm x 26mmRAA-911262025-02-10
00899054002685Valve Assist Blade, Reusable, Stainless Steel, 18mm x 26mmRAA-918262025-02-10
00899054002692Atrial Rake, Reusable, Stainless Steel, 19mm x 24mmRAR-919242025-02-10
00899054002708Atrial Rake, Reusable, Stainless Steel, 19mm x 24mm, Knurled, LongRAR-91924L2025-02-10
00899054002715Atrial Rake, Reusable, Stainless Steel, 29mm x 30mmRAR-929302025-02-10
00899054002722Atrial Rake, Reusable, Stainless Steel, 39mm x 34mmRAR-939342025-02-10
00899054002739Atrial Rake, Reusable, Stainless Steel, 37mm x46mmRAR-939442025-02-10
00899054002814Cobra Surgical Arm, 19cm Length, All Sm Links, Shaft ConnectRSA-91192025-02-10
10899054002828Heart Assist, Single Use, 2 Finger Short, Malleable 36mm W X 54mm LHAF-2SHS2025-02-10
10899054002835Heart Assist, Single Use, 2 Finger Long, Malleable 36mm W X 90mm LHAF-2LGS2025-02-10
10899054002842Heart Assist, Single Use, 3 Finger Short, Malleable 60mm W X 54mm LHAF-3SHS2025-02-10
10899054002859Heart Assist, Single Use, 3 Finger Long, Malleable 60mm W X 90mm LHAF-3LGS2025-02-10
00899054002203Triumph Aortic Perfusion CannulaMPH-0022S2017-03-14
00899054002210Triumph Aortic Perfusion CannulaMPH-0019S2017-03-09

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Primary DI, Brand, Company table
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