FDA UDI
In Commercial Distribution
🇺🇸 United States
Anesthesia screen
DI: 10841736113407
·
Model: 6-020-02-1
·
SKYTRON LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Anesthesia screen
- Primary DI
- 10841736113407
- Version / Model
- 6-020-02-1
- Company Name
- SKYTRON LLC
- Labeler DUNS
- 078375583
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-15
- Public Version
- 1
- Public Version Date
- 2019-10-23
- Public Version Status
- New
- Public Device Record Key
- cdd67e1d-d914-434a-a697-34b6a9fa1b30
Device Description
Anesthesia screen, "L" type, without clamp [(Sure Clamp 6-040-08 recommended ) (1 ea.)]
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
- 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 |
|---|---|---|---|---|
| LWG | Surgical Table Cushion | General, Plastic Surgery | 878.4950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35501 | Anaesthesia screen | A frame-like device designed to provide a barrier between the sterile surgical site (i.e., where the surgeon operates) and the non-sterile area where the anaesthesiologists and other staff work during a procedure. It is typically fixed to the side rail of the operating table, and surgical drapes are hung over it or from it to create the hygienic partition. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10841736113407 | GS1 |
Customer Contacts
- Phone
- 800-759-8766
- [email protected]