FDA UDI
In Commercial Distribution
🇺🇸 United States
Carnegie Surgical LLC
DI: G14144752210
·
Model: 447-5221
·
Carnegie Surgical LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Carnegie Surgical LLC
- Primary DI
- G14144752210
- Version / Model
- 447-5221
- Catalog Number
- 447-5221
- Company Name
- Carnegie Surgical LLC
- Labeler DUNS
- 017636482
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-02
- Public Version
- 1
- Public Version Date
- 2024-09-10
- Public Version Status
- New
- Public Device Record Key
- 2c0496c3-6d23-45b8-9e55-d12215ef8ade
Device Description
FOMON nasal rasp, 7 3/4" (20 cm), TC f.1/2, very coarse (12/14 teeth) with local Tips and Thumb Impression
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KBA | Rasp, Nasal | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35296 | Nasal file/rasp | A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth at the working end(s) designed to remove and profile the cartilage/bone of the nose during ear/nose/throat (ENT) or plastic surgery. It is typically a one-piece instrument available in a variety of sizes and working end designs, including straight and curved ends, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G14144752210 | HIBCC |
Customer Contacts
- Phone
- (609) 249-2697
- [email protected]