FDA UDI
In Commercial Distribution
🇺🇸 United States
IMAGE DIAGNOSTICS INC
DI: 00850977007898
·
Model: PRO KIT, CASE
·
IMAGE DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- IMAGE DIAGNOSTICS INC
- Primary DI
- 00850977007898
- Version / Model
- PRO KIT, CASE
- Catalog Number
- A800-0310
- Company Name
- IMAGE DIAGNOSTICS, INC.
- Labeler DUNS
- 608235214
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2021-12-14
- Public Version
- 2
- Public Version Date
- 2023-06-09
- Public Version Status
- Update
- Public Device Record Key
- a09dc88a-3a41-43d8-9c20-09bac31adef1
Device Description
IDI,PROTEGO "PRO" PROCEDURE KIT,CASE OF 25 POUCHES,#A800-0310
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MMP | Cover, Barrier, Protective | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40655 | Basic diagnostic x-ray system table, powered | A powered/programmable table that is a component of a basic diagnostic x-ray system designed to position and support a patient during a variety of routine/planar or speciality diagnostic procedures requiring the use of a diagnostic x-ray system; it is not a planar tomography nor computed tomography (CT) table. It can be a stationary or mobile unit and is made of radiolucent materials with low x-ray attenuation coefficients. It is not intended for use during interventional radiology/surgery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00850977007881 | GS1 | ||||
| Primary | 00850977007898 | GS1 |
Customer Contacts
- Phone
- 1-978-829-0009
- [email protected]