FDA UDI
In Commercial Distribution
🇺🇸 United States
Spare bulb for REF: 1266.XIII Xenon BrightStar illumination System.
DI: 08717872001081
·
Model: 1266.XD
·
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Spare bulb for REF: 1266.XIII Xenon BrightStar illumination System.
- Primary DI
- 08717872001081
- Version / Model
- 1266.XD
- Catalog Number
- 1266.XD
- Company Name
- D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Labeler DUNS
- 407522184
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 5
- Public Version Date
- 2022-01-21
- Public Version Status
- Update
- Public Device Record Key
- 4fc6a1c0-ab08-4dca-9788-9c81c44878f0
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| MPA | Endoilluminator | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65935 | Ophthalmic procedural light source unit | An electrically-powered, noninvasive device designed to produce light of high intensity, often called cold light, for ophthalmic examination and procedure applications. It is designed as a portable unit with controls whereby light transmission occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., fibreoptic probes and micro light-conducting ophthalmic instruments that provide intraocular illumination). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08717872001081 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K062895 | 000 |