FDA UDI
Not in Commercial Distribution
🇺🇸 United States
iLED7 Surgical Light
DI: 00887761968295
·
Model: 4068210
·
Baxter Medical Systems GmbH + Co. KG
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- iLED7 Surgical Light
- Primary DI
- 00887761968295
- Version / Model
- 4068210
- Company Name
- Baxter Medical Systems GmbH + Co. KG
- Labeler DUNS
- 330961223
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-05
- Public Version
- 4
- Public Version Date
- 2025-06-27
- Public Version Status
- Update
- Public Device Record Key
- c5dcd864-94b1-4090-9d4a-3f0047cd0577
- Distribution End Date
- 2025-04-28
Device Description
iLED 7 Ceiling Duo
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 |
|---|---|---|---|---|
| FSQ | Light, surgical, instrument | General, Plastic Surgery | 878.4580 | 2 |
| FTD | Lamp, surgical | General, Plastic Surgery | 878.4580 | 2 |
| FQP | Lamp, operating-room | General, Plastic Surgery | 878.4580 | 2 |
| FSY | Light, surgical, ceiling mounted | General, Plastic Surgery | 878.4580 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37332 | Operating room light system | An assembly of devices designed to provide specialized sources of light for illumination of a site of medical intervention. It typically consists of a combination of the light heads that may be of equal or unequal size, or a combination of operating and examination/treatment lights (commonly known as satellite lights) mounted on independent rotating counterbalanced arms allowing the positioning of the lights to any position. This device is usually mounted to the ceiling of an operating room (OR) and it may include cameras, visual display units (VDU) or other devices. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00887761968295 | GS1 |
Customer Contacts
- Phone
- +4936715860
- [email protected]