EndoDrill Drive System US

Primary DI
17340179900122
Brand
EndoDrill Drive System US
Company
Bibbinstruments AB
Model
Model X
Device description
Endodrill Drive System is to be used with Endodrill Biopsy Instrument GI . Endodrill System is a surgical instrument used together with a flexible ultrasound endoscope to collect tissue for histological examination.
Published
2026-10-15
Public version status
New
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
FCGBiopsy Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCGBiopsy NeedleGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17340179900122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1734017990012217340179900122

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose endoscopic needle, single-useA flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
213-944-0503info@taewoongusa.com

Regulatory Flags#

DUNS number
352499168
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17340179900078Endodrill Drive SystemModel X3000-012024-01-31
27340179900051Endodrill Biopsy instrument GI 17G130012024-01-31
37340179900058Endodrill Biopsy instrument GI 17G130022024-01-31
17340179900054Endodrill Biopsy instrument GI 17G1005-402024-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00817295021098InradInradFCG2026-10-08
00817295021104InradInradFCG2026-10-08
00817295021111InradInradFCG2026-10-08
00817295021128InradInradFCG2026-10-08
00817295021135InradInradFCG2026-10-08
00817295021142InradInradFCG2026-10-08
00817295021159InradInradFCG2026-10-08
00817295021357InradInradFCG2026-10-08
00817295021364InradInradFCG2026-10-08
00817295021371InradInradFCG2026-10-08
00817295021388InradInradFCG2026-10-08
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10884521833043SharkCoreCovidien LPFCG2026-09-06
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10884521833081SharkCoreCovidien LPFCG2026-09-06
10884521833012BeaconCovidien LPFCG2026-09-05
10884521833029BeaconCovidien LPFCG2026-09-05
10884521833036BeaconCovidien LPFCG2026-09-05
10884521833142BeaconCovidien LPFCG2026-09-05
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10884521833166BeaconCovidien LPFCG2026-09-05
04048223088388ChibaSonoPajunk GmbH MedizintechnologieFCG2026-06-10
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04953170459207Single-use Fine Needle Biopsy (FNB) DeviceOLYMPUS MEDICAL SYSTEMS CORP.FCG2025-12-02
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