FDA.reportPublic FDA data

DeltaCut Biopsy gun

Primary DI
04048223013182
Brand
DeltaCut Biopsy gun
Company
Pajunk GmbH Medizintechnologie
Model
304B000001
Catalog number
304B000001
Device description
DeltaCut Biopsy gun
Published
2019-03-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNWINSTRUMENT, BIOPSY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063233000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063233000DELTACUT (APPARATUS AND CANNULA)PAJUNK GmbH Medizintechnologie2007-04-30KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048223013182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048223013182040482230131824048223013182

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)972-5865info@pajunk-usa.com

Regulatory Flags#

DUNS number
317654283
Device count
1
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048223056165VASCULAR SONO1187-4F0351187-4F0352021-04-02
04048223056172VASCULAR SONO1187-4F0701187-4F0702021-04-02
04048223056189VASCULAR SONO1187-4K0401187-4K0402021-04-02
04048223056196VASCULAR SONO1187-4K0701187-4K0702021-04-02
04048223056202VASCULAR SONO1187-4K1001187-4K1002021-04-02
04048223115947VASCULAR SONO1187-4F0351187-4F0352021-07-07
04048223115954VASCULAR SONO1187-4F0701187-4F0702021-07-07
04048223115961VASCULAR SONO1187-4K0401187-4K0402021-07-07
04048223115978VASCULAR SONO1187-4K0701187-4K0702021-07-07
04048223115985VASCULAR SONO1187-4K1001187-4K1002021-07-07
04048223126561VascularSono1187-4K0701187-4K0702025-06-17
04048223126653VascularSono1187-4K1001187-4K1002025-11-04
04048223126721VascularSono1187-4F0701187-4F0702025-11-04
14048223021153VascularSono1187-4K0701187-4K0702016-08-31
14048223021160VascularSono1187-4K1001187-4K1002016-08-31
14048223021344VascularSono1187-4F0351187-4F0352016-08-31
14048223021504VascularSono1187-4K0401187-4K0402016-08-31
14048223021603VascularSono1187-4F0701187-4F0702016-08-31
04048223122655Tuohy II1170-6I0911170-6I0912026-10-22
04048223122679Tuohy II1170-6K0811170-6K0812026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936666568834CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
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06937278664587CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
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06937278664600CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664617CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664624CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664631CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664648CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664655CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664662CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664679CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664686CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664693CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664709CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664716CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664723CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664730CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664747CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664754CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664761CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664778CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664785CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664792CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664808CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664815CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664822CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664839CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664846CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05