FDA.reportPublic FDA data

Labotect

Primary DI
04046668003287
Brand
Labotect
Company
Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung
Model
Ovarian Biopsy Set No. 2
Catalog number
16784
Device description
Double lumen puncture set with grinded echo marking for aspiration & flushing
Published
2019-10-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQENeedle, Assisted Reproduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQENeedle, Assisted ReproductionObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003056000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003056000OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218Labotect Labor-Technik Gottingen2000-12-13MQE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046668003287PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046668003287040466680032874046668003287

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49551505010info@labotect.com

Regulatory Flags#

DUNS number
317343861
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
04046668002815LabotectInsemination Catheter133722019-10-16
04046668001429LabotectInsemination Catheter133722019-10-16
04046668002235LabotectEmbryo Transfer Catheter 15 cm133652019-10-11
04046668002242LabotectEmbryo Transfer Catheter 19 cm133662019-10-11
04046668003058LabotectEmbryo Transfer Catheter 19 cm146902019-10-11
04046668003317LabotectEmbryo Transfer Catheter 23 cm133692019-10-11
04046668001481Labotect Ovarian Biopsy Set No. 1134382019-10-11
04046668001405LabotectEmbryo Transfer Catheter 15 cm133652019-10-11
04046668001412LabotectEmbryo Transfer Catheter 19 cm133662019-10-11
04046668002266Labotect Ovarian Biopsy Set No. 1134402019-10-11
04046668002273LabotectOvarian Biopsy Set No. 1134412019-10-11
04046668002280LabotectOvarian Biopsy Set No. 1134432019-10-11
04046668002297LabotectOvarian Biopsy Set No. 1134442019-10-11
04046668002310Labotect Ovarian Biopsy Set No. 2134632019-10-11
04046668002860LabotectOvarian Biopsy Set No. 1 134512019-10-11
04046668002877LabotectOvarian Biopsy Set No. 1 134522019-10-11
04046668002884Labotect Ovarian Biopsy Set No. 1134502019-10-11
04046668002945LabotectPuncture needle134272019-10-11
04046668002952LabotectOvarian Biopsy Set No. 113452L2019-10-11
04046668003065LabotectEmbryo Transfer Catheter 19 cm146902019-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841436125915Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2026-07-27
10841436125939Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2026-07-27
10841436125953Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2026-07-27
10841436122211Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
10841436122228Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
10841436122242Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
10841436122266Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
10841436122273Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
10841436122297Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
10841436122310Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
10841436122334Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
10841436122358Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
10841436122365Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
10841436123225Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
10841436123249Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
04580745043709OPU NeedleKITAZATO CORPORATIONMQE2024-05-16
04580745043723OPU NeedleKITAZATO CORPORATIONMQE2024-05-16
04580745043730OPU NeedleKITAZATO CORPORATIONMQE2024-05-16
03700111400801HOC CLASSIC WITH VALVE Aspiration tube 2 x 33 cmLABORATOIRE CCDMQE2023-12-05
03700111400818HOC CLASSIC WITHOUT VALVE Aspiration tube 67 cmLABORATOIRE CCDMQE2023-12-05
03700111400825HOC2 CLASSIC WITHOUT VALVE SOFT PLUGLABORATOIRE CCDMQE2023-12-05
03700111400832OPS CLASSIC WITHOUT VALVELABORATOIRE CCDMQE2023-12-05
03700111400849OPS CLASSIC WITH VALVELABORATOIRE CCDMQE2023-12-05
03700111400863HOC COLLECTION VIAL 30MLLABORATOIRE CCDMQE2023-12-05
03700111400917OPS A.R.T. OF C.C.D. ® WITHOUT VALVELABORATOIRE CCDMQE2023-12-05
03700111400924OPS A.R.T. OF C.C.D. ®WITH VALVELABORATOIRE CCDMQE2023-12-05
03700111400931HOC A.R.T. OF C.C.D.® WITHOUT VALVELABORATOIRE CCDMQE2023-12-05
03700111400948HOC A.R.T. OF C.C.D.® WITH VALVELABORATOIRE CCDMQE2023-12-05
03700111400955HOC2 A.R.T. OF C.C.D.® WITHOUT VALVE SOFT PLUGLABORATOIRE CCDMQE2023-12-05
03700111400962HOC2 A.R.T. OF C.C.D. ®WITH VALVE SOFT PLUGLABORATOIRE CCDMQE2023-12-05