FDA UDI
In Commercial Distribution
🇺🇸 United States
V. Mueller
DI: 10885403100680
·
Model: OP9301
·
CAREFUSION 2200, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- V. Mueller
- Primary DI
- 10885403100680
- Version / Model
- OP9301
- Catalog Number
- OP9301
- Company Name
- CAREFUSION 2200, INC
- Labeler DUNS
- 832696038
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-07
- Public Version
- 2
- Public Version Date
- 2019-10-07
- Public Version Status
- Update
- Public Device Record Key
- d9a173d9-cbce-4b80-8696-e5ce4c9b0133
Device Description
GILLS-WELSH LENS LOOP 7 X 5MM WIDE THIN LOOP OLIVE TIP ON OPPOSITE END OVERALL LENGTH 4-3/4"(12.1CM)
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 |
|---|---|---|---|---|
| HMX | Cannula, ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12319 | Lens loop, reusable | A hand-held, manual, ophthalmic surgical instrument designed for eye lens extraction and gentle manipulation and/or irrigation of eye tissues during an ophthalmic surgical procedure. It typically consists of a small wire loop (frequently serrated) at the distal tip and a handle for easy manipulation; it may also include a channel (e.g., a cannula) which is connected to an external irrigator for irrigation of the eye. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10885403100680 | GS1 |
Customer Contacts
- Phone
- +1(800)323-9088
- [email protected]