FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 10849771013775
·
Model: CS-9113
·
KEY SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
80
Basic Information
- Brand Name
- NA
- Primary DI
- 10849771013775
- Version / Model
- CS-9113
- Catalog Number
- CS9113
- Company Name
- KEY SURGICAL, INC.
- Labeler DUNS
- 604056226
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 80
- Record Status
- Published
- Publish Date
- 2022-07-29
- Public Version
- 2
- Public Version Date
- 2022-10-04
- Public Version Status
- Update
- Public Device Record Key
- e05db419-6139-4bb1-a6e8-347c0519c0da
Device Description
Surgical Tray Corner Protectors, Lime Green
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| LRP | TRAY, SURGICAL | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63494 | Instrument tray corner protector, reusable | A device designed to cover the sharp corners of an instrument tray before the tray is wrapped with sterilization packaging (wrap), to protect the wrap from tearing and the tray corners from damage. It is typically made of synthetic polymer materials. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00849771013778 | GS1 | ||||
| Primary | 10849771013775 | GS1 |
Customer Contacts
- Phone
- +1(800)541-7995
- [email protected]