Identity
- Trade Name
- gSource FDA UDI
- Generic Name
- Nasal file/rasp FDA UDI
- Device Name
- Rasp #3 SE 8 1/2", 7mmx40mm str, downcutting, fine grit serr, TC FDA UDI
- Model / Reference
- gS 61.6843 FDA UDI
- Description
- Rasp #3 SE 8 1/2", 7mmx40mm str, downcutting, fine grit serr, TC FDA UDI
Identifiers
- Catalog Number
- gS 61.6843 FDA UDI
- Primary DI / UDI-DI
- 00840314232397 FDA UDI
- FDA Product Code
- HTR FDA UDI
- GMDN Term
- Nasal file/rasp FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Nasal file/rasp
gSource by Gsource, Llc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nasal file/rasp.
- Ambler Surgical — Ambler Surgical, LLC · Class I
- AESCULAP — AESCULAP, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Parkes nasal rasp — Spiggle & Theis Medizintechnik GmbH · Class I
- HNM MEDICAL — HNM STAINLESS, LLC. · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- MILLENNIUM — AVALIGN TECHNOLOGIES, Inc. · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Gsource, Llc.
Sources (1)
- FDA UDI 46679c2c-d98b-4c2d-a1a9-e9b5d0cd53ec 34 fields · synced May 30, 2026