FDA.reportPublic FDA data

Bonopty Extended Drill

Primary DI
17350031350279
Brand
Bonopty Extended Drill
Company
Apriomed AB
Model
G027
Catalog number
10-1074
Device description
Extended drill that can be used together with AprioMed Bonopty Penetration Set 14G.
Published
2023-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
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
17350031350279PackageGS15In Commercial Distribution
27350031350276PackageGS112In Commercial Distribution
07350031350272PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1735003135027917350031350279
2735003135027627350031350276
07350031350272073500313502727350031350272

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
Length16Centimeter
Outer Diameter1.75Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
631734758
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
07350031350722Bonopty Penetration Set10-107210-10722020-12-04
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

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