FDA.reportPublic FDA data

Cobra Surgical Arm, 19cm Length, All Sm Links, Shaft Connect

Primary DI
00899054002814
Brand
Cobra Surgical Arm, 19cm Length, All Sm Links, Shaft Connect
Company
KDL Medical, Inc.
Model
RSA-9119
Device description
Cobra Surgical Arm, 19cm Length, All 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
00899054002814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00899054002814008990540028148990540028140899054002814

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
03661219320265DELACROIX-CHEVALIERLANDANGERDWS2026-10-11
03661219438601DELACROIX-CHEVALIERLANDANGERDWS2026-10-11
03661219442943DELACROIX-CHEVALIERLANDANGERDWS2026-10-11
03661219528388DELACROIX-CHEVALIERLANDANGERDWS2026-10-11
00190776434236MillenniumAvalign Technologies, Inc.DWS2026-10-09
00190776436216MillenniumAvalign Technologies, Inc.DWS2026-10-08
00190776436254MillenniumAvalign Technologies, Inc.DWS2026-10-08
00190776436315MillenniumAvalign Technologies, Inc.DWS2026-10-08
00190776436353MillenniumAvalign Technologies, Inc.DWS2026-10-08
00190776436377MillenniumAvalign Technologies, Inc.DWS2026-10-08
00190776436438MillenniumAvalign Technologies, Inc.DWS2026-10-08
00190776434410MillenniumAvalign Technologies, Inc.DWS2026-10-07
00190776434489MillenniumAvalign Technologies, Inc.DWS2026-10-07
00190776434298MillenniumAvalign Technologies, Inc.DWS2026-10-06
00190776434359MillenniumAvalign Technologies, Inc.DWS2026-10-06
00190776433307MillenniumAvalign Technologies, Inc.DWS2026-10-05
03661219323785DELACROIX-CHEVALIERLANDANGERDWS2026-09-30
03661219323815DELACROIX-CHEVALIERLANDANGERDWS2026-09-30
03661219323822DELACROIX-CHEVALIERLANDANGERDWS2026-09-30
03661219323839DELACROIX-CHEVALIERLANDANGERDWS2026-09-30
00190776432843MillenniumAvalign Technologies, Inc.DWS2026-09-29
B040MIRSTS0Sterilization TrayGENESEE BIOMEDICAL, INC.DWS2026-09-29
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