FDA UDI
In Commercial Distribution
🇺🇸 United States
Adept Medical Clinician Arm Support
DI: 09421905187619
·
Model: A
·
ADEPT MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Adept Medical Clinician Arm Support
- Primary DI
- 09421905187619
- Version / Model
- A
- Catalog Number
- AM0900
- Company Name
- ADEPT MEDICAL LIMITED
- Labeler DUNS
- 592534619
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-20
- Public Version
- 1
- Public Version Date
- 2022-05-30
- Public Version Status
- New
- Public Device Record Key
- bf6875aa-5a67-430b-8da9-40a6e6b81443
Device Description
To support the Clinicians arm during endoscope guided surgery.
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 |
|---|---|---|---|---|
| 63229 | Operator armrest | A preformed frame designed to provide support for a healthcare provider's hands/wrist/arm during a medical procedure. It is attached to an appropriate procedure table (e.g., operating, treatment) or another supporting device. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09421905187619 | GS1 |