FDA UDI
In Commercial Distribution
🇺🇸 United States
Adato SIL-OL-5000
DI: 00757770516315
·
Model: ES 5000 S
·
Bausch & Lomb Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Adato SIL-OL-5000
- Primary DI
- 00757770516315
- Version / Model
- ES 5000 S
- Catalog Number
- ES 5000 S
- Company Name
- Bausch & Lomb Incorporated
- Labeler DUNS
- 196603781
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-25
- Public Version
- 3
- Public Version Date
- 2019-04-23
- Public Version Status
- Update
- Public Device Record Key
- f68b26c3-aeaa-45f9-aa04-bc07323ce95e
Device Description
ADATO SIL-OL 5000 SYRINGE
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LWL | Fluid, Intraocular | Ophthalmic | 886.4275 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45125 | Vitreous humour replacement medium, postoperative | A fluid or semifluid substance (e.g., silicone oil with or without a perfluorocarbon, or a semifluorinated alkane) intended to be used to compress/unfold the retina (up to weeks/months) to support its reattachment following the operative treatment of severe retinal detachment; it might in addition be intended for transient intraoperative use (e.g., to remove silicone oil residues). Often referred to as a retinal tamponade, it is intended to realign the retina by exerting a force against it without flowing behind it. It is typically removed after a period depending upon clinical findings. It may be supplied in a prefilled syringe or other container. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00757770516315 | GS1 |