Identity
- Trade Name
- andorate® Irrigation Tubing FDA UDI
- Generic Name
- Surgical irrigation tubing set, single-use FDA UDI
- Model / Reference
- GAR083 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04897106955046 FDA UDI
- FDA Product Code
- OCX FDA UDI
- GMDN Term
- Surgical irrigation tubing set, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
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: Surgical irrigation tubing set, single-use
andorate® Irrigation Tubing by GA Health Company Limited — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical irrigation tubing set, single-use.
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- Endo-Flo — Davol Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- GA Health Company Limited
Sources (2)
- FDA UDI faf39c5d-bfef-4f04-8e09-fd9a4106b4d4 32 fields · synced Oct 7, 2026
- EUDAMED 1 fields · synced Jun 3, 2026