FDA UDI
In Commercial Distribution
🇺🇸 United States
Straight Arm
DI: 00858340006127
·
Model: SARM
·
Del Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Straight Arm
- Primary DI
- 00858340006127
- Version / Model
- SARM
- Company Name
- Del Medical, Inc.
- Labeler DUNS
- 078671236
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-14
- Public Version
- 1
- Public Version Date
- 2021-06-22
- Public Version Status
- New
- Public Device Record Key
- 1b89c4ba-4a31-439d-88ab-264fb59e06ad
Device Description
The Straight Arm is an economical and space-efficient X-ray system that can perform a comprehensive range of radiographic procedures. Its flexibility permits imaging of patients sitting or standing, as well as recumbent when optional mobile table is present
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
- MR Safe
- 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 |
|---|---|---|---|---|
| IXY | Holder, Radiographic Cassette, Wall-Mounted | Radiology | 892.1880 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36433 | X-ray film subtraction unit | A device bearing light sources beneath a transparent top used for the subtraction of x-ray film images. In subtraction, two series are needed, one exposed without, and one with contrast injected during the angiographic run. By placing one x-ray film over the other, the reproduction of the vessels will be outlined. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858340006127 | GS1 |