FDA UDI
In Commercial Distribution
🇺🇸 United States
IMAGE DIAGNOSTICS, INC.
DI: 00850977007607
·
Model: LOW-PROFILE VAB
·
IMAGE DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- IMAGE DIAGNOSTICS, INC.
- Primary DI
- 00850977007607
- Version / Model
- LOW-PROFILE VAB
- Catalog Number
- A100-2244
- Company Name
- IMAGE DIAGNOSTICS, INC.
- Labeler DUNS
- 608235214
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-09
- Public Version
- 3
- Public Version Date
- 2023-06-09
- Public Version Status
- Update
- Public Device Record Key
- 0cca1b87-05ca-4a09-ac1b-5e57a4c5e187
Device Description
IDI,VASCULAR ARM BOARD,LOW-PROFILE,#A100-2244
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
- 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 |
|---|---|---|---|---|
| NOD | Board, Arm (Wtih Cover), Non-Sterile | General, Plastic Surgery | 878.3910 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37047 | Arm procedure positioner, reusable | A preformed device designed to support and stabilize a patient's arm in a desired position during a medical procedure [e.g., orthopaedic surgery, anaesthesia administration, blood donation, intravenous (IV) infusion, physical therapy massage]. Also known as an arm posturing device or armboard, it is typically constructed as an elongated, curved, cushioned surface, and is typically attached or fixed onto a side rail, operation/examination table, blood donor couch, or a chair, and has adjustable height, tilt, rotation, and lock positioning capabilities. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850977007607 | GS1 |
Customer Contacts
- Phone
- 1-978-829-0009
- [email protected]