FDA.report

Boss Instruments

Primary DI
00888515112865
Brand
Boss Instruments
Company
BOSS INSTRUMENTS, LTD., INC.
Model
65-6716
Catalog number
65-6716
Device description
Cooley Coarctation Clamp, 8 3/4", ang shanks
Published
2016-09-21
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

Related Records

Contact Domains

Product Codes

CodeName
DXCCLAMP, VASCULAR

Product Code Classifications

CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888515112865PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888515112865008885151128658885151128650888515112865

GMDN Terms

TermDefinition
Aortic coarctation clampA hand-held manual surgical instrument designed for the temporary, atraumatic compression of the section of aorta effected by coarctation (i.e., a congenital narrowing of the aorta in the vicinity of the insertion of the ductus arteriosus). It typically has a self-retaining, scissors-like design with ring handles and is made of high-grade stainless steel; it may utilize inserts made of various materials (e.g., carbide). It is available in various sizes and has serrated blades that are either straight or curved. The serrated region has a central, non-serrated trough running its length to prevent trauma to the enclosed vessel. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(540)832-5000orders@bossinst.com
+1(540)832-5000orders@bossinstruments.com

Regulatory Flags

DUNS number
848522678
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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

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00888515231351BOSS Instruments90-7042P90-7042P2024-12-11
00888515231368BOSS Instruments90-704490-70442024-12-11
00888515231382BOSS Instruments90-7044P90-7044P2024-12-11
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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
20197344138897NAMICMEDLINE INDUSTRIES, INC.DXC2026-03-16
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00192896122727Debakey Coarctation ClampSONTEC INSTRUMENTS, INC.DXC2026-03-10
00884450846032Safeguard Radial™Merit Medical Systems, Inc.DXC2026-02-20
00840479401027enableCV IntraClude™ Intra-Aortic Occlusion DeviceENABLECV INC.DXC2026-02-06
18022057015881DeTACH Aortic Cross Clamp Head-LargeCORCYM SRLDXC2026-02-03
08022057015891DeTACH Aortic Cross Clamp Head- MediumCORCYM SRLDXC2026-02-03
18022057015904DeTACH Aortic Cross Clamp Head-SmallCORCYM SRLDXC2026-02-03
08022057015914DeTACH Aortic Cross Clamp Delivery SystemCORCYM SRLDXC2026-02-03
08022057015921DeTACH Aortic Cross Clamp Quick Release DeviceCORCYM SRLDXC2026-02-03
08022057015945DeTACH Aortic Cross Clamp Delivery DeviceCORCYM SRLDXC2026-02-03
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54026704930840PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
54026704930857PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
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54026704930895PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
00192896121638Debakey Neonatal ClampSONTEC INSTRUMENTS, INC.DXC2025-06-17
00192896121645Debakey Neonatal ClampSONTEC INSTRUMENTS, INC.DXC2025-06-17