FDA UDI
In Commercial Distribution
🇺🇸 United States
Another Hand
DI: 06009900639604
·
Model: 1
·
WISMED PL SP Z O O
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Another Hand
- Primary DI
- 06009900639604
- Version / Model
- 1
- Company Name
- WISMED PL SP Z O O
- Labeler DUNS
- 850665825
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-17
- Public Version
- 1
- Public Version Date
- 2025-03-25
- Public Version Status
- New
- Public Device Record Key
- df4bc487-a43a-445e-9a7c-9ef8a0eb863d
Device Description
The multi-joint, flexible medical holding/positioning device, approximately 20 cm long and made of thermoplastics, features a spring-loaded clamp mechanism on both ends conveniently able to attach to various diameter instruments/devices.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EYJ | Holder, Ureteral Catheter | Gastroenterology, Urology | 876.5130 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65126 | Surgical instrument handle grip | A device designed specifically to be attached to the handle (or holding portion) of a surgical instrument to provide grip for improved manipulation of the handle during surgical procedures. It is typically a synthetic polymer device designed for attachment to a handle and is not intended to provide a physical sterile barrier between the handle and the hand of a healthcare professional (i.e., not a handle cover). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06009900639604 | GS1 |
Customer Contacts
- Phone
- +1 (513) 604-3430
- [email protected]
- Phone
- +1 800.822.0314
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- – 104 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- – 104 Degrees Fahrenheit