FDA UDI
In Commercial Distribution
🇺🇸 United States
Curaplex
DI: 00812574026092
·
Model: 301-H1126-2
·
TRI-ANIM HEALTH SERVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Curaplex
- Primary DI
- 00812574026092
- Version / Model
- 301-H1126-2
- Catalog Number
- 301-H1126-2
- Company Name
- TRI-ANIM HEALTH SERVICES, INC.
- Labeler DUNS
- 010712461
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-15
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 83cb440b-e29b-46b0-ad68-33670ffba01c
Device Description
Curaplex Penlite LED Handle
Device Characteristics
- Single Use
- Yes
- 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
- MR Unsafe
- Direct Marking Exempt
- Yes
- 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
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|---|---|
| Package | 00812574026108 | GS1 | BX | 20 | In Commercial Distribution | |
| Primary | 00812574026092 | GS1 | ||||
| Package | 00818834020459 | GS1 | CS | 6 | In Commercial Distribution |