FDA.reportPublic FDA data

Sterile Single-Use Multi-Angle Needle Guide-Probe Cover Kit

Primary DI
00841912106905
Brand
Sterile Single-Use Multi-Angle Needle Guide-Probe Cover Kit
Company
PROTEK MEDICAL PRODUCTS, INC.
Model
5364
Catalog number
5364
Device description
Sterile Single-Use Multi-Angle Needle Guide-Probe Cover Kit for use with DBSI2C for Esaote SI2C41 Ultrasound Transducers
Published
2021-05-17
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

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
KKXDrape, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
KKXDrape, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970893000
K973958000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970893000ULTRASOUND TRANSDUCER DRAPEProtek Medical Products, Inc.1997-10-20FYA
K973958000GENERAL PURPOSE ATL NEEDLE GUIDE KITProtek Medical Products, Inc.1998-01-22ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841912106902PackageGS124In Commercial Distribution
00841912106905PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084191210690210841912106902
00841912106905008419121069058419121069050841912106905

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.

Regulatory Flags#

DUNS number
965417181
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
10841912104717Probe Storage Covers11402021-09-20
00841912100507CT Control Cover100610062016-09-16
00841912100538CT Monitor Cover 100910092016-09-16
00841912100545CT Control Cradle Cover101010102016-09-16
00841912100552System Cover Kit101110112016-09-16
00841912100583Neoprobe Sterile Sleeve Kit with PullUp/pull off extension102710272016-09-16
00841912100590System Drape102810282016-09-16
00841912100606PullUp Instrument Cover103010302016-09-16
00841912100637RTP Universal Stepper/Stabilizer Drape12022016-09-16
00841912100644System Drape Kit121212122016-09-16
00841912100651System Drape Kit121312132016-09-16
00841912100668Isoloader Surgical Drape1214S5521332016-09-16
00841912100675System Drape with Pocket121712172016-09-16
00841912100866Cord Cover Kit194019402016-09-16
00841912104369The Guard Sterile Barrier1205KM12052016-09-16
00841912105021ClingTouch Sterile Disposable Monitor Cover018001802017-09-29
00841912105335Sterile Disposable System Drape Kit128012802017-11-17
00841912105618Terminator XRT Sterile Drape1228TXRT-SD2018-06-06
00841912106035Sterile Sleeve for Gamma Finder III103110312019-06-10
00841912106042System Cover107410742020-11-06

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Primary DI, Brand, Company table
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04580826928291PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928468PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
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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
10801902196665ARROWTELEFLEX INCORPORATEDKKX2026-07-28
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
00841436125895Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126052Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126403Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27