Labotect 13366

GUDID 04046668001412

Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung

Assisted reproduction transfer catheter/set

• Primary Device ID: 04046668001412
• NIH Device Record Key: 6b6a01e6-edba-4c6e-9fd1-66f99a1e0ca6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Labotect
• Version Model Number: Embryo Transfer Catheter 19 cm
• Catalog Number: 13366
• Company DUNS: 317343861
• Company Name: Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49551505010
• Email: info@labotect.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046668001412 [Package]; Contains: 04046668002242; Package: cardboard box [20 Units]; In Commercial Distribution
GS1	04046668002242 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000950

FDA Product Code

• MQF: Catheter, Assisted Reproduction

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-21
• Device Publish Date: 2019-10-11

On-Brand Devices [Labotect]

• 04046668002259: Embryo Transfer Catheter 23 cm
• 04046668003294: Single lumen puncture set with corroded echo marking for aspiration only
• 04046668003287: Double lumen puncture set with grinded echo marking for aspiration & flushing
• 04046668003270: Single lumen puncture set with corroded echo marking for aspiration only
• 04046668003225: Single lumen puncture set with corroded echo marking for aspiration & flushing
• 04046668003072: Single lumen puncture set with corroded echo marking for aspiration only
• 04046668003065: Single packed
• 04046668002952: Single lumen puncture set with grinded echo marking for aspiration only
• 04046668002945: Single lumen puncture needle with grinded echo marking for aspiration only
• 04046668002884: Single lumen puncture set with grinded echo marking for aspiration only
• 04046668002877: Single lumen puncture set with grinded echo marking for aspiration only
• 04046668002860: Single lumen puncture set with grinded echo marking for aspiration only
• 04046668002310: Double lumen puncture set with grinded echo marking for aspiration & flushing
• 04046668002297: Single lumen puncture set with corroded echo marking for aspiration only
• 04046668002280: Single lumen puncture set with corroded echo marking for aspiration & flushing
• 04046668002273: Single lumen puncture set with corroded echo marking for aspiration only
• 04046668002266: Single lumen puncture set with grinded echo marking for aspiration only
• 04046668001412: Embryo Transfer Catheter 19 cm
• 04046668001405: Embryo Transfer Catheter 15 cm
• 04046668001481: Single lumen puncture set with grinded echo marking for aspiration only
• 04046668001429: Insemination Catheter