FDA UDI
In Commercial Distribution
🇺🇸 United States
Carnegie Surgical LLC
DI: G14167216220
·
Model: 672-1622
·
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
- G14167216220
- Version / Model
- 672-1622
- Catalog Number
- 672-1622
- Company Name
- Carnegie Surgical LLC
- Labeler DUNS
- 017636482
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-19
- Public Version
- 1
- Public Version Date
- 2025-02-27
- Public Version Status
- New
- Public Device Record Key
- a3f452c7-181f-49fc-9cc2-21944bd8ee14
Device Description
Frontotemporal Dissector, 9" (23 cm), 7mm tip, Slightly Curved
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 |
|---|---|---|---|---|
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11290 | Open-surgery dissector | A hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, comes in various shapes and sizes. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G14167216220 | HIBCC |
Customer Contacts
- Phone
- (609) 249-2695
- [email protected]