FDA.reportPublic FDA data

Disposable Platform Blades

Primary DI
00899054002623
Brand
Disposable Platform Blades
Company
KDL Medical, Inc.
Model
DPB-8000S
Device description
Disposable Platform Blades for Reusable Activator Drive
Published
2023-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
00899054002623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00899054002623008990540026238990540026230899054002623

GMDN Terms#

Term, Definition table
TermDefinition
Sternum spreaderA self-locking surgical instrument designed to force apart the surgically-split sternum (the breastbone) to permit surgical cardiac intervention within the thoracic cavity. This device will typically have two interchangeable profiled, pivoted blades (self-adjusting their angle as the instrument is opened) at the distal end that hook over the margins of the severed sternum, and a ratchet mechanism along its horizontal bar to adjust the blades, parting the sternum and maintain its set position once it has been set. It is also known as a sternum retractor and is available in various designs and sizes. It is made of high-grade stainless steel. This is a reusable device.

Contacts#

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

Regulatory Flags#

DUNS number
791048924
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00899054002005Sof-Flo Atraumatic Coronary Artery ShuntSHT-1210S2017-03-09
00899054002012Sof-Flo Atraumatic Coronary Artery ShuntSHT-1215S2017-03-14
00899054002029Bulb Tip Coronary Artery ShuntsSHB-1215S2017-03-09
00899054002036Bulb Tip Coronary Artery ShuntsSHB-3030S2017-03-14
00899054002043Bulb Tip Coronary Artery ShuntsSHB-3025S2017-03-14
00899054002050Bulb Tip Coronary Artery ShuntsSHB-3040S2017-03-14
00899054002074Sof-Flo Atraumatic Coronary Artery ShuntSHT-1213S2017-03-14
00899054002081Sof-Flo Atraumatic Coronary Artery ShuntSHT-1218S2017-03-14
00899054002104Sof-Flo Atraumatic Coronary Artery ShuntSHT-1220S2017-03-14
00899054002128Sof-Flo Atraumatic Coronary Artery ShuntSHT-1225S2017-03-14
00899054002135Bulb Tip Coronary Artery ShuntsSHB-1218S2017-03-14
00899054002159Bulb Tip Coronary Artery ShuntsSHB-1220S2017-03-14
00899054002173Bulb Tip Coronary Artery ShuntsSHB-1225S2017-03-14
00899054002180Bulb Tip Coronary Artery ShuntsSHB-1230S2017-03-14
00899054002265Viper II Apical LiftAPI-700VS2017-08-23
00899054002272Viper II Blower MisterBLM-700MS2017-08-23
00899054002296Foot Pedal, Dual ValveFTV-10202017-08-24
00899054002302FasTract Sternal RetractorRTC-10002017-08-24
00899054002319FasTract Sternal Retractor, Deep BladesRTC-1000-C012017-08-24
00899054002401FasTract Modified Sternal Retractor, Deep BladesRTC-1000-C022017-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776408732MillenniumAvalign Technologies, Inc.DWS2026-08-03
03661219141778DELACROIX-CHEVALIERLANDANGERDWS2026-08-02
03661219141785DELACROIX-CHEVALIERLANDANGERDWS2026-08-02
14026704916679PILLINGTELEFLEX INCORPORATEDDWS2026-08-01
00190776407438MillenniumAvalign Technologies, Inc.DWS2026-07-31
00190776407513MillenniumAvalign Technologies, Inc.DWS2026-07-31
00190776407315MillenniumAvalign Technologies, Inc.DWS2026-07-28
00190776407360MillenniumAvalign Technologies, Inc.DWS2026-07-28
00190776405830MillenniumAvalign Technologies, Inc.DWS2026-07-26
03661219438663DELACROIX-CHEVALIERLANDANGERDWS2026-07-25
00190776404222MillenniumAvalign Technologies, Inc.DWS2026-07-24
00190776405748MillenniumAvalign Technologies, Inc.DWS2026-07-24
00190776405779MillenniumAvalign Technologies, Inc.DWS2026-07-24
00190776403973MillenniumAvalign Technologies, Inc.DWS2026-07-22
00190776403348MillenniumAvalign Technologies, Inc.DWS2026-07-21
00190776403683MillenniumAvalign Technologies, Inc.DWS2026-07-21
00190776403768MillenniumAvalign Technologies, Inc.DWS2026-07-21
00190776400521MillenniumAvalign Technologies, Inc.DWS2026-07-19
00190776402051MillenniumAvalign Technologies, Inc.DWS2026-07-19
00190776402068MillenniumAvalign Technologies, Inc.DWS2026-07-19
00190776400309MillenniumAvalign Technologies, Inc.DWS2026-07-17
04058749009347NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749010060NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749122671NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749122725NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749122794NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749125917NAFehling Instruments GmbH & Co. KGDWS2026-07-17
00190776397197MillenniumAvalign Technologies, Inc.DWS2026-07-16
00190776395643MillenniumAvalign Technologies, Inc.DWS2026-07-14
00190776396763MillenniumAvalign Technologies, Inc.DWS2026-07-14