FDA UDI
In Commercial Distribution
🇺🇸 United States
Sterilizable Handles
DI: 00887761967250
·
Model: 4025708
·
Baxter Medical Systems GmbH + Co. KG
Product Codes
5
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Sterilizable Handles
- Primary DI
- 00887761967250
- Version / Model
- 4025708
- Company Name
- Baxter Medical Systems GmbH + Co. KG
- Labeler DUNS
- 330961223
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-11
- Public Version
- 1
- Public Version Date
- 2023-07-19
- Public Version Status
- New
- Public Device Record Key
- c697bf60-73fb-48d9-8dfb-7f18d3713bfb
Device Description
Sterilizable Central Handle, 1 pc
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
- No
- 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 |
|---|---|---|---|---|
| FSS | Light, surgical, floor standing | General, Plastic Surgery | 878.4580 | 2 |
| FSQ | Light, surgical, instrument | General, Plastic Surgery | 878.4580 | 2 |
| FQP | Lamp, operating-room | General, Plastic Surgery | 878.4580 | 2 |
| FTD | Lamp, surgical | General, Plastic Surgery | 878.4580 | 2 |
| FSY | Light, surgical, ceiling mounted | General, Plastic Surgery | 878.4580 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44975 | Medical equipment handle cover, reusable | A device designed specifically to cover the handle of a piece of medical equipment (e.g., operating light) to provide a physical sterile barrier between the handle and the hand of a healthcare professional, e.g., during a surgical procedure. It is typically a rigid polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00887761968554 | GS1 | 3 | In Commercial Distribution | ||
| Primary | 00887761967250 | GS1 |
Customer Contacts
- Phone
- +4936715860
- [email protected]