FDA.reportPublic FDA data

Cobra Surgical Arm, 19cm Length, Lg/Med/Sm Links, Shaft Connect

Primary DI
00899054002654
Brand
Cobra Surgical Arm, 19cm Length, Lg/Med/Sm Links, Shaft Connect
Company
KDL Medical, Inc.
Model
RSA-9019
Device description
Cobra Surgical Arm, 19cm Length, Lg/Med/Sm Links, Shaft Connect Cobra Surgical Arm, 16cm Length, Lg/Med/Sm Links, Shaft Connect
Published
2025-02-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00899054002654PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00899054002654008990540026548990540026540899054002654

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.

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
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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
03661219527688DELACROIX-CHEVALIERLANDANGERDWS2026-09-27
00724995286651V. MuellerSTERIS Deutschland GmbHDWS2026-09-25
00724995286668V. MuellerSTERIS Deutschland GmbHDWS2026-09-25
00724995286675V. MuellerSTERIS Deutschland GmbHDWS2026-09-25
00724995286682V. MuellerSTERIS Deutschland GmbHDWS2026-09-25
10884389855416NAMICMEDLINE INDUSTRIES, INC.DWS2026-09-25
04058749012446NAFehling Instruments GmbH & Co. KGDWS2026-09-21
00192896123762TAVR Removal SetSONTEC INSTRUMENTS, INC.DWS2026-09-18
B040PHR10Premature Hinged Sternal RetractorGENESEE BIOMEDICAL, INC.DWS2026-09-18
00190776429119MillenniumAvalign Technologies, Inc.DWS2026-09-04
00884450456217Merit Medical®Merit Medical Systems, Inc.DWS2026-09-04
00884450456224Merit Medical®Merit Medical Systems, Inc.DWS2026-09-04
00884450456231Merit Medical®Merit Medical Systems, Inc.DWS2026-09-04
04058749008944NAFehling Instruments GmbH & Co. KGDWS2026-09-04
04058749012521NAFehling Instruments GmbH & Co. KGDWS2026-09-04
04058749036350NAFehling Instruments GmbH & Co. KGDWS2026-09-04
04058749122626NAFehling Instruments GmbH & Co. KGDWS2026-09-04
00190776423933MillenniumAvalign Technologies, Inc.DWS2026-08-27
00190776423971MillenniumAvalign Technologies, Inc.DWS2026-08-27
00190776424114MillenniumAvalign Technologies, Inc.DWS2026-08-27
00190776424138MillenniumAvalign Technologies, Inc.DWS2026-08-27
00884450450970Merit Medical®Merit Medical Systems, Inc.DWS2026-08-27
00190776419707MillenniumAvalign Technologies, Inc.DWS2026-08-25
00190776420284MillenniumAvalign Technologies, Inc.DWS2026-08-25
00190776420390MillenniumAvalign Technologies, Inc.DWS2026-08-25
04058749004496NAFehling Instruments GmbH & Co. KGDWS2026-08-25
00190776417130MillenniumAvalign Technologies, Inc.DWS2026-08-19
00190776416973MillenniumAvalign Technologies, Inc.DWS2026-08-18
00190776417000MillenniumAvalign Technologies, Inc.DWS2026-08-18
00198506094064ELMED INCORPORATEDELMED INCORPORATEDDWS2026-08-18