FDA UDI
In Commercial Distribution
🇺🇸 United States
Sklar®
DI: 40649111034320
·
Model: 21-285
·
SKLAR CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
Basic Information
- Brand Name
- Sklar®
- Primary DI
- 40649111034320
- Version / Model
- 21-285
- Company Name
- SKLAR CORPORATION
- Labeler DUNS
- 006966006
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2018-08-08
- Public Version
- 1
- Public Version Date
- 2018-09-10
- Public Version Status
- New
- Public Device Record Key
- 4750aebb-2077-4e8f-a662-bac148b88478
Device Description
MAGILL CATH FCP 8" CHILD BX12
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- 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
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEN | FORCEPS, GENERAL & PLASTIC SURGERY | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33089 | Airway tube forceps, single-use | A sterile, hand-held instrument used for grasping a tube [e.g., a catheter or an endotracheal (ET) tube] for its insertion and/or extraction into/from the airways, or for grasping obstructive objects for their removal from the airways. Commonly known as a Magill's forceps, it typically has a scissors-like design with ring handles and is made of strong disposable plastic materials or stainless steel. It is available in various sizes and the working end will typically have grasping blades that have small ringed loops or S-shaped distal working ends. The blades are serrated to provide extra grip. It is typically used by emergency medical services (EMS). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 40649111034320 | GS1 | ||||
| Unit of Use | 00649111034322 | GS1 |