Identity
- Trade Name
- Transem Spherical FDA UDI
- Generic Name
- Assisted reproduction transfer catheter/set FDA UDI
- Device Name
- Embryo transfer catheter, spherical tip. FDA UDI
- Model / Reference
- TSET24SAS FDA UDI
- Description
- Embryo transfer catheter, spherical tip. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20888937972348 FDA UDI
- 510(k) Number
- K161547 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
Yes
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
No
FDA UDI
Category: Assisted reproduction transfer catheter/set
Transem Spherical by Origio A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Assisted reproduction transfer catheter/set.
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- Kitazato ET Catheter — KITAZATO CORPORATION · Class II
- Kitazato ET Catheter — KITAZATO CORPORATION · Class II
- Labotect — Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung · Class II
Cleared under the same submission
K161547 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Origio A/S
Sources (1)
- FDA UDI 9d621048-1240-4b7d-af5a-b10bab0f6483 35 fields · synced Jun 7, 2026