FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable Conventional Laryngoscope Handle
DI: G272D78620
·
Model: D7862
·
Maco International
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Disposable Conventional Laryngoscope Handle
- Primary DI
- G272D78620
- Version / Model
- D7862
- Catalog Number
- D7862
- Company Name
- Maco International
- Labeler DUNS
- 152941683
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-16
- Public Version
- 1
- Public Version Date
- 2024-01-24
- Public Version Status
- New
- Public Device Record Key
- fd41fa29-f74b-4869-963f-c6f78bb265be
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CCW | Laryngoscope, Rigid | Anesthesiology | 868.5540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47806 | Laryngoscope handle, single-use | A clean, non-sterile, hand-held segment of a laryngoscope (i.e., non-endoscopic rigid type) designed to manipulate the laryngoscope blade during airway access and intubation. It is a cylindrical device that contains batteries/light-emitting cells to provide the 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 single-use device; the batteries/light-emitting cells are intended to be removed for reuse before the device is discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G272D78620 | HIBCC |