FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Key Surgical Plastic Instruments
DI: 00849771027119
·
Model: KS-385
·
KEY SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- Key Surgical Plastic Instruments
- Primary DI
- 00849771027119
- Version / Model
- KS-385
- Catalog Number
- KS385
- Company Name
- KEY SURGICAL, INC.
- Labeler DUNS
- 604056226
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2020-12-21
- Public Version
- 6
- Public Version Date
- 2023-05-08
- Public Version Status
- Update
- Public Device Record Key
- f3343262-b35b-4496-837c-3fc3b4052b8c
- Distribution End Date
- 2023-05-08
Device Description
Plastic Instruments, Towel and Utility Clamp, Purple.
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
- 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 |
|---|---|---|---|---|
| HXD | Clamp | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34961 | Towel clamp, reusable | A surgical instrument designed to hold together surgical towels and/or drapes, or for securing other devices such as cables/leads, during an operation/intervention. It is made of metallic or polymer materials and is available in a variety of sizes and designs (e.g., two blades joined at their midpoints, single alpha-shaped device, various gripping jaws); it is commonly known as a towel clamp, towel forceps, or towel clip. 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 | 00849771039518 | GS1 | ||||
| Primary | 00849771027119 | GS1 |
Customer Contacts
- Phone
- +1(800)541-7995
- [email protected]