FDA.reportPublic FDA data

Compass International

Primary DI
B169DBNP1010TP0
Brand
Compass International
Company
Compass International
Model
DBNP-10-10TP
Catalog number
DBNP-10-10TP
Device description
Cygnus-PFS TracPlus Disposable Biopsy Needle
Published
2016-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
GAANeedle, Aspiration And Injection, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B169DBNP1010TP0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue biopsy needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to percutaneously obtain a specimen of soft tissue, typically for hsitopathological examination. The device is usually attached to a syringe for the aspiration of the specimen; it is available in a variety of lengths, diameters (bores), and tip configurations (e.g., straight or curved). This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
809466410
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009258129COMPASS CT Adaptation Stereotactic SystemPION-20CT-NBAR-102026-03-18
00860009258136COMPASS Stereotactic Retractor SystemPION-20RE-202026-03-18
00860009258105COMPASS CYGNUS-PFS IGS SystemCYG-PFSN-10TPCYG-PFSN-10TP2026-01-29
00860009258112COMPASS Stereotactic SystemPION-20PION-202026-01-29
B169RU1500Compass InternationalRU-150RU-1502016-08-26
B169RU3000Compass InternationalRU-300RU-3002016-08-26
B169CYGERG10D0Compass InternationalCYG-ERG-10DCYG-ERG-10D2016-08-12
B169CYG10B2TP0Compass InternationalCYG-10-B2TPCYG-10-B2TP2016-09-13
B169CYG10BTP0Compass InternationalCYG-10-BTPCYG-10-BTP2016-09-13
B169CYG10LPTP0Compass InternationalCYG-10-LPTPCYG-10-LPTP2016-09-13
B169CYG10LSTP0Compass InternationalCYG-10-LSTPCYG-10-LSTP2016-09-13
B169CYG10PTP0Compass InternationalCYG-10-PTPCYG-10-PTP2016-09-13
B169CYG10STP0Compass InternationalCYG-10-STPCYG-10-STP2016-09-13
B169CYG14FSCT100Compass InternationalCYG-14F-SCT10CYG-14F-SCT102016-09-13
B169CYG4FCT100Compass InternationalCYG-4F-CT10CYG-4F-CT102016-08-12
B169CYG4FCT10TP0Compass InternationalCYG-4F-CT10TPCYG-4F-CT10TP2016-09-13
B169CYG5FNPT100Compass InternationalCYG-5F-NPT10CYG-5F-NPT102016-09-13
B169CYG5FNPT10TP0Compass InternationalCYG-5F-NPT10TPCYG-5F-NPT10TP2016-09-13
B169CYG9FSCT100Compass InternationalCYG-9F-SCT10CYG-9F-SCT102016-09-13
B169CYG9FSCT10TP0Compass InternationalCYG-9F-SCT10TPCYG-9F-SCT10TP2016-09-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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