FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 07613327056204
·
Model: 0240080230
·
STRYKER CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 07613327056204
- Version / Model
- 0240080230
- Catalog Number
- 0240080230
- Company Name
- STRYKER CORPORATION
- Labeler DUNS
- 187502109
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-08
- Public Version
- 1
- Public Version Date
- 2019-10-16
- Public Version Status
- New
- Public Device Record Key
- e53e599b-5396-469c-9cd9-3952bbfae230
Device Description
SDP1000 Digital Color Printer
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 |
|---|---|---|---|---|
| KQM | CAMERA, SURGICAL AND ACCESSORIES | General, Plastic Surgery | 878.4160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17508 | Video printer | A device designed for making printed (hard) copies of medical video images. These can be taken by digital cameras or image processing results of different imaging devices or systems [e.g., ultrasound (US), magnetic resonance imaging (MRI), computed tomography (CT) or radiographic images]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613327056204 | GS1 |
Customer Contacts
- Phone
- +1(866)624-4422
- [email protected]
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius