FDA.reportPublic FDA data

Non-implantable, needle guide, reusable

Primary DI
05704916001568
Brand
Non-implantable, needle guide, reusable
Company
BK MEDICAL APS
Model
UA1327
Device description
Reusable Endfire Biopsy Guide
Published
2019-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
05704916001568PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05704916001568057049160015685704916001568

GMDN Terms#

Term, Definition table
TermDefinition
Nonimplantable needle guide, reusableA non-powered device designed to lead a needle into its proper course when performing a clinical and/or surgical procedure. Dedicated needle guides are available for many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, guides for ultrasound-guided percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a reusable device intended to be sterilized/disinfected prior to use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method
"[""Hydrogen Peroxide"", ""Peracetic Acid""]"
Chlorine Dioxide;Hydrogen Peroxide;Peracetic Acid
Hydrogen Peroxide;Peracetic Acid

Contacts#

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

Regulatory Flags#

DUNS number
310093901
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

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

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08800013510112L8-17HAlpinion Medical Systems Co., Ltd.ITX2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28
08800290027266PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-04-03
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