FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Adept Medical ArmSure
DI: 09421905187374
·
Model: AM0640
·
ADEPT MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Adept Medical ArmSure
- Primary DI
- 09421905187374
- Version / Model
- AM0640
- Catalog Number
- AM0640
- Company Name
- ADEPT MEDICAL LIMITED
- Labeler DUNS
- 592534619
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-20
- Public Version
- 2
- Public Version Date
- 2025-09-12
- Public Version Status
- Update
- Public Device Record Key
- 9af32136-89ce-4fb3-94d1-4c9e2154819e
- Distribution End Date
- 2025-05-01
Device Description
• ArmSure: To support the patient’s arm. • Arm Strap: To immobilise the patient’s arm, protecting the sterile field. • X-Ray Shield: To provide scatter radiation protection for clinician.
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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Liquid Chemical
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CCX | Support, Patient Position | Anesthesiology | 868.6820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40900 | Radiological arm/leg positioner | A device designed to ensure adequate positioning and immobilization of the patient's arms and/or legs during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. It may include various configurations such as a frame, board, cushion, preformed pad, or shoulder tension rope, strap, or handle grip that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09421905187374 | GS1 |