FDA UDI
In Commercial Distribution
🇺🇸 United States
M844 F40 / M822 F40
DI: 07630003526233
·
Model: 000000000010448142
·
Leica Microsystems (Schweiz) AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- M844 F40 / M822 F40
- Primary DI
- 07630003526233
- Version / Model
- 000000000010448142
- Company Name
- Leica Microsystems (Schweiz) AG
- Labeler DUNS
- 480198725
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-22
- Public Version
- 2
- Public Version Date
- 2022-04-08
- Public Version Status
- Update
- Public Device Record Key
- 15d5d1c1-72f9-4aae-a6eb-4b4bf7229f44
Device Description
F40 stand for M844/M820 - for Leica surgical operating microscope systems: M844 F40, M822 F40
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
- 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 |
|---|---|---|---|---|
| FSO | MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY | General, Plastic Surgery | 878.4700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32817 | Ophthalmic slit lamp, surgical | An electrically-powered ophthalmic magnification instrument, usually stereoscopic, designed for use in the operating room (OR) to magnify minute structures within the eye or its surroundings in the performance of ophthalmic surgical procedures which require high magnification by transmitted light. It is typically equipped with motorized focusing, adjustable magnification mechanisms (zoom), backup lamps, and inclined tubes that permit the surgeon to see the field from a vertical perspective while keeping the head erect. Dual or multiple observation capability and the optical integration of still, motion picture and video cameras are common features. It can be fixed or mobile. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07630003526233 | GS1 |
Customer Contacts
- Phone
- +1(847)8213502
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify |
Storage Conditions
- Type
- Special Storage Condition, Specify