FDA UDI
In Commercial Distribution
🇺🇸 United States
1688
DI: 07613327481884
·
Model: 1688210080
·
STRYKER CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 1688
- Primary DI
- 07613327481884
- Version / Model
- 1688210080
- Catalog Number
- 1688210080
- Company Name
- STRYKER CORPORATION
- Labeler DUNS
- 187502109
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-05
- Public Version
- 1
- Public Version Date
- 2020-08-13
- Public Version Status
- New
- Public Device Record Key
- e53bcd6e-0b76-43f0-9b92-3f9bbad24ea6
Device Description
4K Microscope Camera Head, C-Mount
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
- No
- 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 |
|---|---|---|---|---|
| EPT | MICROSCOPE, SURGICAL | General, Plastic Surgery | 878.4700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60490 | Video camera surgical microscope system | An assembly of noninvasive devices intended to transmit detailed, magnified, video images from a surgical site (non-specific) to a monitor to facilitate visualization of the surgical site by the surgeon; it may include recording equipment for teaching applications. It typically includes a fibreoptic telescope, illumination hardware, video camera, positioning arm, appropriate hardware/cabling, and may include recording unit, monitor and transportation cart. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613327481884 | GS1 |
Customer Contacts
- Phone
- +1(866)624-4422
- [email protected]