FDA.reportPublic FDA data

Bonopty Penetration Set

Primary DI
07350031350722
Brand
Bonopty Penetration Set
Company
Apriomed AB
Model
10-1072
Catalog number
10-1072
Device description
Manually operated, sterile, single use coaxial bone biopsy system
Published
2020-12-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
17350031350729PackageGS15Not in Commercial Distribution
27350031350726PackageGS112Not in Commercial Distribution
07350031350722PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1735003135072917350031350729
2735003135072627350031350726
07350031350722073500313507227350031350722

GMDN Terms#

Term, Definition table
TermDefinition
Bone biopsy needleA sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone, bone marrow and/or tumour from any bone of the body. It is typically inserted through a bone access cannula under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and supplied with an ejector rod to remove the biopsy. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length9.5Centimeter
Needle Gauge14Gauge

Contacts#

Phone, Email table
PhoneEmail
+46184301440info@apriomed.com

Regulatory Flags#

DUNS number
631734758
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350031350623Bonopty Penetration Set10-106210-10622020-12-02
07350031350630Bonopty Biopsy Set10-106310-10632020-12-01
07350031350739Bonopty Biopsy Set10-107310-10732020-12-04
07350031350746Bonopty Extended Drill10-107410-10742020-12-04
07350031350821Bonopty Penetration Set10-108210-10822020-12-04
07350031350838Bonopty Biopsy Set10-108310-10832020-12-04
07350031351194Gangi-SoftGuard Coaxial NeedleSG12-121SG12-1212019-01-21
07350031351217Gangi-SoftGuard Coaxial NeedleSG13-071SG13-0712019-01-21
07350031351224Gangi-SoftGuard Coaxial NeedleSG13-121SG13-1212019-01-21
07350031351231Gangi-SoftGuard Coaxial NeedleSG13-171SG13-1712019-01-21
07350031351248Gangi-SoftGuard Coaxial NeedleSG15-071SG15-0712019-01-21
07350031351255Gangi-SoftGuard Coaxial NeedleSG15-121SG15-1212019-01-21
07350031351262Gangi-SoftGuard Coaxial NeedleSG15-171SG15-1712019-01-21
07350031351279Gangi-SoftGuard Coaxial NeedleSG17-071SG17-0712019-01-21
07350031351286Gangi-SoftGuard Coaxial NeedleSG17-121SG17-1212019-01-21
07350031351293Gangi-SoftGuard Coaxial NeedleSG17-171SG17-1712019-01-21
07350031351330Gangi-HydroGuard Coaxial NeedleHG15-121HG15-1212019-01-21
07350031351347Gangi-HydroGuard Coaxial NeedleHG15-171HG15-1712019-01-21
07350031351354Gangi-HydroGuard Coaxial NeedleHG17-121HG17-1212019-01-21
07350031351361Gangi-HydroGuard Coaxial NeedleHG17-171HG17-1712019-01-21

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Primary DI, Brand, Company table
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00884450681299Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681374Bedford™Merit Medical Systems, Inc.GAA2026-08-21
10198956515482CARDINAL HEALTHCardinal Health 200, LLCGAA2026-07-27
05060212050038Aspirating Needle 335 x 3.5mm (18g) with LuerDTR MEDICAL LIMITEDGAA2026-06-11
05060212050021Aspirating Needle 335 x 3.5mm (18g) with LuerDTR MEDICAL LIMITEDGAA2026-06-10
10192253057461TurkelCardinal Health 200, LLCGAA2026-05-13
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10192253025262MonojectCardinal Health 200, LLCGAA2026-01-16
10192253025125MonojectCardinal Health 200, LLCGAA2026-01-12
08800176593069WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
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08800176592451WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592468WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08