FDA UDI
In Commercial Distribution
🇺🇸 United States
Pre-Install Set
DI: 00887761968127
·
Model: 4068051
·
Baxter Medical Systems GmbH + Co. KG
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pre-Install Set
- Primary DI
- 00887761968127
- Version / Model
- 4068051
- 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
- 2022-12-15
- Public Version
- 2
- Public Version Date
- 2023-02-09
- Public Version Status
- Update
- Public Device Record Key
- 6ff9756b-13e1-4a49-a430-3f25b8d04a82
Device Description
Pre-Install Set iLED 7
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
- Yes
- 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 |
|---|---|---|---|---|
| FQP | Lamp, operating-room | General, Plastic Surgery | 878.4580 | 2 |
| FTD | Lamp, surgical | General, Plastic Surgery | 878.4580 | 2 |
| FSQ | Light, surgical, instrument | General, Plastic Surgery | 878.4580 | 2 |
| FSY | Light, surgical, ceiling mounted | General, Plastic Surgery | 878.4580 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35954 | Medical device service rail | A device designed to provide a secure, rapid, and safe method of mounting and organizing medical and non-medical devices being used in the vicinity for patient treatment/care. It will typically be used in hospital wards, treatment rooms or an intensive care unit (ICU). It is usually fixed to a medical device service rail system, a medical device, or directly to a wall and in some cases it may be fixed to mobile devices. It will have a preformed cross-section incorporating a safety design compatible to the clamps expected to be mounted. It may be supplied in regular lengths which must be cut accordingly when fitted, or in prefabricated lengths. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00887761968127 | GS1 |
Customer Contacts
- Phone
- +4936715860
- [email protected]