FDA.reportPublic FDA data

Heart Assist, Single Use, 2 Finger Short, Malleable 36mm W X 54mm L

Primary DI
00899054002821
Brand
Heart Assist, Single Use, 2 Finger Short, Malleable 36mm W X 54mm L
Company
KDL MEDICAL, INC.
Model
HAF-2SHS
Device description
Heart Assist, Single Use, 2 Finger Short, Malleable 36mm W X 54mm L
Published
2025-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00899054002821PrimaryGS10
10899054002828Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00899054002821008990540028218990540028210899054002821
1089905400282810899054002828

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument assist arm system, manually-adjustedA manually-powered/-adjusted device assembly intended to be used to hold, maintain in a desired position, and enable positional adjustment of surgical and/or endoscopic instruments during an endoscopic examination/surgical procedure (i.e., during use). It typically consists of rigid or semi-rigid arms with joints, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table) or is mounted on a mobile (on wheels) base.

Contacts#

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

Regulatory Flags#

DUNS number
791048924
Device count
5
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00899054002067Mannequin™ Endoventricular ShaperVRD-0080S2017-05-23
00899054002098Mannequin™ Endoventricular ShaperVRD-0090S2017-05-23
00899054002111Mannequin™ Endoventricular ShaperVRD-0100S2017-05-23
00899054002142Mannequin™ Endoventricular ShaperVRD-0110S2017-05-23
00899054002166SVR System without PatchSVC-0080S2017-05-23
00899054002197Mannequin™ Endoventricular ShaperVRD-0120S2017-05-23
00899054002227Mannequin™ Endoventricular ShaperVRD-0130S2017-05-23
00899054002234Mannequin™ Endoventricular ShaperVRD-0140S2017-05-23
00899054002241Mannequin™ Endoventricular ShaperVRD-0150S2017-05-23
00899054002258Mannequin™ Endoventricular ShaperVRD-0085S2017-05-23
00899054002326SVR System without PatchSVC-0085S2017-05-23
00899054002333SVR System without PatchSVC-0090S2017-05-23
00899054002340SVR System without PatchSVC-0100S2017-05-23
00899054002357SVR System without PatchSVC-0110S2017-05-23
00899054002364SVR System without PatchSVC-0120S2017-05-23
00899054002371SVR System without PatchSVC-0130S2017-05-23
00899054002388SVR System without PatchSVC-0140S2017-05-23
00899054002395SVR System without PatchSVC-0150S2017-05-23
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

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Primary DI, Brand, Company table
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