FDA UDI
In Commercial Distribution
🇺🇸 United States
Looking Glass
DI: 30845854050723
·
Model: AV8500
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Looking Glass
- Primary DI
- 30845854050723
- Version / Model
- AV8500
- Catalog Number
- AV8500
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-18
- Public Version
- 2
- Public Version Date
- 2023-09-26
- Public Version Status
- Update
- Public Device Record Key
- aa39c88b-bb22-4cb3-bcbc-e6c45cd37ea8
Device Description
Visuaization Cart, 120 VAC
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 |
|---|---|---|---|---|
| KQM | CAMERA, SURGICAL AND ACCESSORIES | General, Plastic Surgery | 878.4160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35124 | Medical device integration rack | A device that is designed as an instrument rack (maybe cabinet-like with closed sides) and is used for mounting and organizing several medical devices that are intended to interact (integrated instrumentation). It is typically mobile (on wheels) and has built-in grounded outlets, pull-out shelves, working surfaces, and may even be equipped with a built-in transformer. This device, when supplied with the instrumentation fitted, will become a system and will require product identification of the whole as a system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 10845854050729 | GS1 | ||||
| Primary | 30845854050723 | GS1 |
Customer Contacts
- Phone
- +1(866)426-6633
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- KEEP DRY
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 93 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 158 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal