FDA UDI
In Commercial Distribution
🇺🇸 United States
ASSISTARM
DI: 10845854043486
·
Model: AA-CON250
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ASSISTARM
- Primary DI
- 10845854043486
- Version / Model
- AA-CON250
- Catalog Number
- AA-CON250
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-28
- Public Version
- 3
- Public Version Date
- 2023-09-25
- Public Version Status
- Update
- Public Device Record Key
- e799f73f-fdd7-4d34-984a-f1d0aec5d270
Device Description
AssistArm Connector
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FWZ | Operating Room Accessories Table Tray | General, Plastic Surgery | 878.4950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58984 | Intraoperative freestanding patient positioning frame | A non-sterile device designed to support and stabilize a patient's arm or leg in a desired posture during a surgical procedure, typically an orthopaedic procedure where it is intended to be used with an arm or leg ring. It is typically in the form of a frame with a base and support arch that is not attached to a parent device (freestanding); it is typically constructed of plastic materials. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10845854043486 | GS1 | ||||
| Direct Marking | 20845854043483 | GS1 |
Customer Contacts
- Phone
- +1(866)426-6633
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 95 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 35 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- KEEP DRY