Aligned Medical Solutions
- Primary DI
- B098CH10201
- Brand
- Aligned Medical Solutions
- Company
- Aligned Medical Solutions
- Model
- CH1020
- Catalog number
- CH1020
- Device description
- ABDOMINAL PACK - 10KG OR LESS
- Published
- 2023-11-14
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B098CH10201 | Package | HIBCC | 10 | In Commercial Distribution |
| B098CH10200 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| General surgical procedure kit, non-medicated, single-use | A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 15 Degrees Celsius | 30 Degrees Celsius | |
Contacts
| Phone | Email |
|---|
| 18006377056 | CUSTOMERSERVICE@ALIGNEDMEDICALSOLUTIONS.COM |
Regulatory Flags
- DUNS number
- 106580145
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
alignedmedicalsolutions.com