Identity
- Trade Name
- LiNA OperaScope™ Tubing & Drape kit FDA UDI
- Generic Name
- Hysteroscopic/cystoscopic distention tubing set FDA UDI
- Device Name
- Tubing & drape Kit intended for hysteroscopy and cystoscopy FDA UDI
- Model / Reference
- OP-TDK-6 FDA UDI
- Description
- Tubing & drape Kit intended for hysteroscopy and cystoscopy FDA UDI
Identifiers
- Catalog Number
- OP-TDK-6 FDA UDI
- Primary DI / UDI-DI
- 05708265012480 FDA UDI
- FDA Product Code
- PXU FDA UDI
- GMDN Term
- Hysteroscopic/cystoscopic distention tubing set FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hysteroscopic/cystoscopic distention tubing set
LiNA OperaScope™ Tubing & Drape kit by Lina Medical ApS — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Lina Medical ApS
Sources (1)
- FDA UDI 92c49a87-bed8-44a0-892b-99d7bc419061 35 fields · synced Jun 8, 2026