FDA.reportPublic FDA data

Labotect

Primary DI
04046668002877
Brand
Labotect
Company
Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung
Model
Ovarian Biopsy Set No. 1
Catalog number
13452
Device description
Single lumen puncture set with grinded echo marking for aspiration only
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
04046668002877PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046668002877040466680028774046668002877

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument used for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. The device may have a single or double lumen and may include a needle guide, such as those used with ultrasound. This is a single-use device.

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
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
04046668003072Labotect Ovarian Biopsy Set No. 1151382019-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
03700111400979OVO A.R.T. OF C.C.D.® NEEDLE 30CM G17LABORATOIRE CCDMQE2023-12-05
03700111400993OOCYTE RETRIEVAL NEEDLE30CM G17LABORATOIRE CCDMQE2023-12-05
03700111401006OOCYTE RETRIEVAL NEEDLE 25CM G17LABORATOIRE CCDMQE2023-12-05