Identity
- Trade Name
- Pediatric Grooved Tip Sucker FDA UDI
- Generic Name
- Surgical irrigation/aspiration handpiece, single-use FDA UDI
- Device Name
- A hand-held device designed to regulate and direct a stream of pressurized fluid (e.g., sterile water or saline) and as an alternative provide aspiration (suction), to a surgical site, for the purpose of irrigating and clearing debris from the field of intervention. It is fitted with a long syringe-like nozzle that is activated by the user, typically through a push-type control(s). This device is typically a component of a surgical irrigation/aspiration system used for ENT or neurological surgery. This is a single-use device. FDA UDI
- Model / Reference
- 201036-000 FDA UDI
- Description
- A hand-held device designed to regulate and direct a stream of pressurized fluid (e.g., sterile water or saline) and as an alternative provide aspiration (suction), to a surgical site, for the purpose of irrigating and clearing debris from the field of intervention. It is fitted with a long syringe-like nozzle that is activated by the user, typically through a push-type control(s). This device is typically a component of a surgical irrigation/aspiration system used for ENT or neurological surgery. This is a single-use device. FDA UDI
Identifiers
- Catalog Number
- 201036-000 FDA UDI
- Primary DI / UDI-DI
- B0662010360000 FDA UDI
- 510(k) Number
- K801400 FDA UDI
- FDA Product Code
- DTS FDA UDI
- GMDN Term
- Surgical irrigation/aspiration handpiece, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4420 FDA UDI
- Commercial Distribution
- Not 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
Pediatric Grooved Tip Sucker by Novosci Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K801400 also covers:
- ADULT DEBRIDEMENT SUCKER HEX HANDLE — NOVOSCI CORP.
- ADULT GROOVED TIP SUCKER — NOVOSCI CORP.
- ADULT GROOVED TIP SUCKER — NOVOSCI CORP.
- ADULT HEX HANDLE GROOVED TIP SUCKER — NOVOSCI CORP.
- ADULT SUMP SUCKER — NOVOSCI CORP.
- ADULT SUMP SUCKER — NOVOSCI CORP.
- ADULT SUMP SUCKER HEX HANDLE — NOVOSCI CORP.
- ADULT TIP SUCKER — NOVOSCI CORP.
- ADULT TIP SUCKER HEX HANDLE SHORT — NOVOSCI CORP.
- ADULT TIP SUCKER HEX HANDLE WITH VENT — NOVOSCI CORP.
- ADULT TONSIL TIP SUCKER — NOVOSCI CORP.
- HEX HANDLE ADULT SUMP SUCKER — NOVOSCI CORP.
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
- Manufacturer
- Novosci Corp.
Sources (1)
- FDA UDI 2ce9b764-42dd-4afb-b32e-fa5fac4b8109 36 fields · synced May 30, 2026