FDA UDI
In Commercial Distribution
🇺🇸 United States
Universal Cassette 35cmx43cm(IP 35cmx43cm)Kit
DI: 08809466040023
·
Model: CA01
·
Digiray Corp.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Universal Cassette 35cmx43cm(IP 35cmx43cm)Kit
- Primary DI
- 08809466040023
- Version / Model
- CA01
- Company Name
- Digiray Corp.
- Labeler DUNS
- 557815751
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-02
- Public Version
- 5
- Public Version Date
- 2020-02-07
- Public Version Status
- Update
- Public Device Record Key
- e1129214-b28d-4b87-85d2-e2f21ba049a0
Device Description
The Universal Cassette 35cmx43cm(IP 35cmx43cm)Kit is acquired X-ray images. and Transfer the image to your computer through the FireCR.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | Radiology | 892.1680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35437 | X-ray film cassette, manual | A device used in medical imaging applications to shield x-ray film from exposure to room light during transport and insertion into a diagnostic imaging system, film formatter, or film processor. It is typically designed for use with a particular imaging system or image formatting unit and consists of a plastic or metal housing with removable metal or plastic inserts. Some film cassettes used in x-ray applications can incorporate an x-ray grid into the cassette design. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809466040023 | GS1 |
Customer Contacts
- Phone
- 0427103763
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 35 | Centimeter | |
| Length | 43 | Centimeter | |
| Weight | 1.9 | Kilogram |