FDA.reportPublic FDA data

Chiba

Primary DI
04048223085271
Brand
Chiba
Company
Pajunk GmbH Medizintechnologie
Model
201S070150
Catalog number
201S070150
Device description
Chiba 22G (0,70) x 150mm with bevel, without graduation, with wings,
Published
2025-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Sterile
true
Single use
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
K063697000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063697000SPECIAL SPROTTE, CHIBA, DR STEINHOFF KITPAJUNK GmbH Medizintechnologie2007-02-14KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048223064696PackageGS110In Commercial Distribution
04048223085271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048223064696040482230646964048223064696
04048223085271040482230852714048223085271

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length150Millimeter
Needle Gauge22Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1 770-493-6832info@pajunk-usa.com

Regulatory Flags#

DUNS number
317654283
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
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
06937278664563CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664570CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664587CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
06937278664594CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-11-05
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