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Labotect
FDA UDIClass II (US FDA UDI)
by Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung
Identity
- Trade Name
- Labotect FDA UDI
- Generic Name
- Assisted reproduction transfer catheter/set FDA UDI
- Model / Reference
- Embryo Transfer Catheter 15 cm FDA UDI
Identifiers
- Catalog Number
- 13365 FDA UDI
- Primary DI / UDI-DI
- 04046668002235 FDA UDI
- 510(k) Number
- K000950 FDA UDI
- FDA Product Code
- MQF FDA UDI
- GMDN Term
- Assisted reproduction transfer catheter/set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6110 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Assisted reproduction transfer catheter/set
Labotect by Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Assisted reproduction transfer catheter/set.
- FRYDMAN® CLASSIC 4.5 — LABORATOIRE CCD · Class II
- The Inseminator — CooperSurgical, Inc. · Class II
- STANDARD INTRA UTERINE INSIMINATION CANNULA — LABORATOIRE CCD · Class II
- VitaVitro — Shenzhen Vitavitro Bio-Tech Co., Ltd. · Class II
- Trackable Intra Uterine Insemination Catheter Open Tip — ALLWIN MEDICAL DEVICES, INC. · Class II
- Kitazato ET Catheter — KITAZATO CORPORATION · Class II
- Kitazato ET Catheter — KITAZATO CORPORATION · Class II
- INVENTCATH ECO — LABORATOIRE CCD · Class II
Cleared under the same submission
K000950 also covers:
- Labotect — Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung
- Labotect — Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung
- Labotect — Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung
- Labotect — Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
Sources (1)
- FDA UDI d48ebe35-563f-42ef-a066-d07a317e8ded 35 fields · synced May 31, 2026