FDA UDI
In Commercial Distribution
🇺🇸 United States
Bausch + Lomb
DI: 00757770435432
·
Model: E3097 BP
·
Bausch & Lomb Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Bausch + Lomb
- Primary DI
- 00757770435432
- Version / Model
- E3097 BP
- Catalog Number
- E3097 BP
- Company Name
- Bausch & Lomb Incorporated
- Labeler DUNS
- 196603781
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-30
- Public Version
- 1
- Public Version Date
- 2025-08-07
- Public Version Status
- New
- Public Device Record Key
- fd3bdde3-feda-4ac0-b20e-124360c3d667
Device Description
BASE PLUG
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HRH | Trephine, Manual, Ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32822 | Corneal trephine manual instrument | A hand-held, ophthalmic surgical instrument, constructed as a one-piece handle with trephine (not an exchangeable component) that is manually rotated with downward pressure by a surgeon in order to cut and remove circular pieces of corneal tissue (corneal buttons). The trephine portion consists of a shaft that has at its working end an extremely sharp, bevelled, cylindrical cutting edge. Healthy tissue may be taken from cadavers for transplant to the recipient, where the defect cornea is cut and removed for acceptance of the replacement. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00757770435432 | GS1 |