FDA.reportPublic FDA data

Single-Use Biplane Biopsy Guide

Primary DI
05704916000721
Brand
Single-Use Biplane Biopsy Guide
Company
BK MEDICAL APS
Model
UA1322-S
Device description
Sterile packed. Bore diameter 1.6 mm; angle of insertion 19° to the long axis of the transducer
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FCGBiopsy Needle
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCGBiopsy NeedleGastroenterology, Urology2
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05704916000738PackageGS118In Commercial Distribution
05704916000721PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05704916000738057049160007385704916000738
05704916000721057049160007215704916000721

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 different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
310093901
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
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
05704916001360Rectosigmoidoscope with ObturatorUA06732025-04-30

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