FDA UDI
In Commercial Distribution
🇺🇸 United States
Pashley Laryngoscope
DI: 00192896122192
·
Model: 1412-568
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Pashley Laryngoscope
- Primary DI
- 00192896122192
- Version / Model
- 1412-568
- Catalog Number
- 1412-568
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-30
- Public Version
- 1
- Public Version Date
- 2025-11-07
- Public Version Status
- New
- Public Device Record Key
- 9ff8c43f-1ef0-4adc-b435-5ec4fac65a4e
Device Description
Pashley Laryngoscope Narrow End With Suction
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Dry Heat Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CCW | LARYNGOSCOPE, RIGID | Anesthesiology | 868.5540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67482 | Rigid bladed intubation laryngoscope, optical, reusable | A hand-held device intended for the visual examination of the trachea, and to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It features a curved or straight blade of various designs and lengths that can be hinged/interchanged or integral. Anatomical images are transmitted to an eyecup at the proximal end of the device through relayed lens optics or a fibreoptic bundle; it may additionally be used in conjunction with a digital camera/screen (not included). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00192896122192 | GS1 |
Customer Contacts
- Phone
- +1(800)821-7496
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 6 | Millimeter |