FDA.reportPublic FDA data

Non-implantable needle guide, single-use

Primary DI
05704916001698
Brand
Non-implantable needle guide, single-use
Company
Bk Medical ApS
Model
UA1353-SIP
Device description
Non-implantable needle guide, single-use
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173569000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173569000Ultrasound System 1300Bk Medical Aps2018-02-23IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05704916001698PackageGS18In Commercial Distribution
05704916001681PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05704916001698057049160016985704916001698
05704916001681057049160016815704916001681

GMDN Terms#

Term, Definition table
TermDefinition
Needle guide, single-useA rigid, non-powered device designed to direct a sharp 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 guides for urethral injections, 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. Disposable imaging-supportive devices (e.g., ultrasound transducer cover) may be included with the device. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+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
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00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
03701104600420T-LiteSONOSCANNERITX2026-08-25
04580826920721PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920769PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920806PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926365PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926396PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926501PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926518PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926532PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926556PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826927881PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928291PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928468PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928628PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928703PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928956PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
08800290029376CA2-13MSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036169PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036237BCC2-13SAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
00841517112684C5-1FUJIFILM SONOSITE, INC.ITX2026-08-07
00841436122078Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436122900Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436124294Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27