FDA UDI
In Commercial Distribution
🇺🇸 United States
Carnegie Surgical LLC
DI: G1414045210
·
Model: 404-521
·
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
- G1414045210
- Version / Model
- 404-521
- Catalog Number
- 404-521
- Company Name
- Carnegie Surgical LLC
- Labeler DUNS
- 017636482
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-26
- Public Version
- 1
- Public Version Date
- 2023-04-03
- Public Version Status
- New
- Public Device Record Key
- aa184b14-a7d7-44ec-a775-75e7bf9bc621
Device Description
Laryngoscope conventional reusable handle, small (pen light) (requires 2AA batteries, not included), chrome plated
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 |
|---|---|---|---|---|
| CCW | Laryngoscope, Rigid | Anesthesiology | 868.5540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46830 | Laryngoscope handle, reusable | The hand-held segment of a laryngoscope (i.e., non-endoscopic rigid type) used to manipulate the laryngoscope blade during airway access and intubation. It is a cylindrical device that contains the batteries/light-emitting cells that provide energy/light for the airway-illuminating feature of the laryngoscope (e.g., small light bulb, fibreoptics), and can accommodate various blades. It is available in various sizes and may be magnetic resonance imaging (MRI) compatible. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G1414045210 | HIBCC |
Customer Contacts
- Phone
- (609) 249-2696
- [email protected]