Identity
- Trade Name
- NOVATECH® TALCAIR™ FDA UDI
- Generic Name
- Endoscopic spray catheter, single-use FDA UDI
- Model / Reference
- 109001T FDA UDI
Identifiers
- Catalog Number
- 109001T FDA UDI
- Primary DI / UDI-DI
- EBES109001T0 FDA UDI
- 510(k) Number
- K151832 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Endoscopic spray catheter, 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
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: Endoscopic spray catheter, single-use
Novatech® Talcair™ by Novatech — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic spray catheter, single-use.
- Spray Catheter — Micro-Tech (Nanjing) Co., Ltd. · Class I
- Measuring Jug 250 — Chaplet International Pvt Ltd · Class I
- IRRIGATION SET SIMPLE WAY — LD Medicare · Class IIa
- Spray Catheter — Micro-Tech (Nanjing) Co., Ltd. · Class I
- RoboClean — Era Endoscopy Srl · Class IIa
- Forceps Jar 30 x 80 — Chaplet International Pvt Ltd · Class I
- Trans Urethral Resection Set (TUR Set) — Poly Medicure Limited · Class IIa
- Measuring Jug 500 — Chaplet International Pvt Ltd · Class I
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
- Novatech
Sources (1)
- FDA UDI 180c0d65-498c-44b4-917f-cabb2499734d 36 fields · synced May 30, 2026