FDA.reportPublic FDA data

FINESSE®

Primary DI
10801741083928
Brand
FINESSE®
Company
Bard Peripheral Vascular, Inc.
Model
FS10105
Catalog number
FS10105
Device description
FINESSE® Ultra Introducer Stylet, 10G x 105mm
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNWINSTRUMENT, BIOPSY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093068000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093068000FINESSE ULTRA BREAST BIOSPY SYSTEM DRIVER - BLUE, PINK, PROBE FO1BLU, FOIPNK, F14105USC.R. Bard, Inc.2009-11-10KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741083928PackageGS15In Commercial Distribution
00801741083921PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174108392810801741083928
00801741083921008017410839218017410839210801741083921

GMDN Terms#

Term, Definition table
TermDefinition
Nonimplantable needle guide, single-useA rigid, non-powered device designed to lead a needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, image-guided (e.g., ultrasound, MRI) for percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length105Millimeter
Needle Gauge10Gauge

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)321-4254medical.services@crbard.com

Regulatory Flags#

DUNS number
135057938
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741000331UltraClip® II Breast Tissue Marker8610178610172015-09-25
00801741032004SenoMark® Ultra Breast Tissue MarkerSMEC7CSMEC7C2015-10-02
00801741032011SenoMark® Ultra Breast Tissue MarkerSMEC7RSMEC7R2015-10-02
00801741032028SenoMark® Ultra Breast Tissue MarkerSMEC10CSMEC10C2015-10-01
00801741032035SenoMark® Ultra Breast Tissue MarkerSMEC10RSMEC10R2015-10-01
00801741032042SenoMark® Ultra Breast Tissue MarkerSMEC12CSMEC12C2015-10-01
00801741032059SenoMark® Ultra Breast Tissue MarkerSMEC12RSMEC12R2015-10-02
00801741032066SenoMark® Ultra Breast Tissue MarkerSMMA11CSMMA11C2015-10-01
00801741032073SenoMark® Ultra Breast Tissue MarkerSMMA11RSMMA11R2015-10-01
00801741032080SenoMark® Ultra Breast Tissue MarkerSMAT9CSMAT9C2015-10-02
00801741032097SenoMark® Ultra Breast Tissue MarkerSMAT9RSMAT9R2015-10-02
00801741032103SenoMark® Ultra Breast Tissue MarkerSMAT12CSMAT12C2015-10-01
00801741032110SenoMark® Ultra Breast Tissue MarkerSMAT12RSMAT12R2015-10-01
00801741032127SenoMark® Ultra Breast Tissue MarkerSMEV9CSMEV9C2015-10-02
00801741032134SenoMark® Ultra Breast Tissue MarkerSMEV9RSMEV9R2015-10-02
00801741032219UltraClip® Dual Trigger Breast Tissue Marker862017D862017D2015-09-25
00801741032226UltraClip® Dual Trigger Breast Tissue Marker862017DL862017DL2015-09-25
00801741032233UltraClip® Dual Trigger Breast Tissue Marker863017D863017D2015-09-25
00801741032240UltraClip® Dual Trigger Breast Tissue Marker863017DL863017DL2015-09-25
00801741032257UltraClip® Dual Trigger Breast Tissue Marker864017D864017D2015-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867543904Arthrex®ARTHREX, INC.KNW2026-09-25
00888867543911Arthrex®ARTHREX, INC.KNW2026-09-25
00888867543928Arthrex®ARTHREX, INC.KNW2026-09-25
00888867543935Arthrex®ARTHREX, INC.KNW2026-09-25
08681672056520MaxiCore-M Reusable Automatic Biopsy GunGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIKNW2026-09-22
00810131882983BMAN BCOR Bone Marrow Aspirate KitSurgentec, LLCKNW2026-08-19
00810131884697BMAN BCOR Bone Marrow Aspirate Kit (with Clip)Surgentec, LLCKNW2026-08-19
00884450476079CorVocet™Merit Medical Systems, Inc.KNW2026-08-18
00884450476093CorVocet™Merit Medical Systems, Inc.KNW2026-08-18
06937278634917CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634924CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634931CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634962CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634979CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634986CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635013CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635020CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635037CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635068CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635075CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635082CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635112CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635129CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635136CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635167CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635174CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635181CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
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