FDA.reportPublic FDA data

Single Use Needle Guide

Primary DI
05704916000899
Brand
Single Use Needle Guide
Company
Bk Medical ApS
Model
UA1339
Device description
Sterile-packed. Bore diameter 1.6 mm; angle of insertion 0° to the long axis of the transducer
Published
2016-12-09
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
FCGBiopsy Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCGBiopsy NeedleGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161960000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161960000bk2300Bk Medical Aps2016-10-17IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05704916000899PackageGS118In Commercial Distribution
05704916000882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05704916000899057049160008995704916000899
05704916000882057049160008825704916000882

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4544528100info@bkultrasound.com
+4544528100support@bkmedical.com
+4544528100info@bkmedical.com

Regulatory Flags#

DUNS number
310093901
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
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
05704916000684Single-Use Biopsy guide UA1257-S142016-09-17
05704916000707Extended, Single-Use Biopsy Guide UA1257-S17E2016-09-17
05704916000721Single-Use Biplane Biopsy Guide UA1322-S2016-09-17
05704916000745Single-Use Biplane Biopsy Guide UA1322-S142016-09-17
05704916000769Single-Use Endfire Biopsy Guide UA1323-S2016-09-17
05704916000783Single-Use Dual Biopsy Guide UA1329-S2016-09-17
05704916000806Single-Use Needle Guide UA13352016-09-17
05704916000820Single-Use Needle Guide UA13362016-09-17
05704916000844Single-Use Needle Guide UA13372016-09-17
05704916000868Single-Use Needle Guide UA13382016-09-17
05704916000882Single Use Needle GuideUA13392016-12-09
05704916000967Disposable Needle GuideUA13442025-04-30
05704916000981Single-Use Needle Guide UA13452016-09-17
05704916001001Single-Use Needle Guide UA13462016-09-17
05704916001681Non-implantable needle guide, single-useUA1353-SIP2022-12-07
05704916000288Foot SwitchUA23522025-05-07
05704916000318Wireless Remote ControlUA23612025-05-07
05704916001612Wireless Remote ControlUA23702025-05-07
05704916001346Water Standoff CollarUA06712025-04-30
05704916001353Rectosigmoidoscope with ObturatorUA06722025-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800025901588BEXCORE Breast Biopsy NeedleMedicalPark CO.,LTD.FCG2026-06-01
08800025901601BEXCORE Breast Biopsy NeedleMedicalPark CO.,LTD.FCG2026-06-01
08800025901854BEXCORE Breast Biopsy NeedleMedicalPark CO.,LTD.FCG2026-06-01
08033860002398BIOPSYBELLBIOPSYBELL SRLFCG2023-10-23
08033860002633BIOPSYBELLBIOPSYBELL SRLFCG2023-10-23
08033860019976BIOPSYBELLBIOPSYBELL SRLFCG2023-10-23
08033860027179BIOPSYBELLBIOPSYBELL SRLFCG2023-10-23
08033860043421BIOPSYBELLBIOPSYBELL SRLFCG2023-10-23
08033860043438BIOPSYBELLBIOPSYBELL SRLFCG2023-10-23
08033860002572BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860016272BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860027810BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041847BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041854BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041861BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041878BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041885BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041892BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041908BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041915BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041922BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041939BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041946BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041953BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041960BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860001728BIOPSYBELLBIOPSYBELL SRLFCG2023-07-03
08033860001742BIOPSYBELLBIOPSYBELL SRLFCG2023-07-03
08033860001766BIOPSYBELLBIOPSYBELL SRLFCG2023-07-03
08033860002558BIOPSYBELLBIOPSYBELL SRLFCG2023-07-03
08033860017361BIOPSYBELLBIOPSYBELL SRLFCG2023-07-03