FDA UDI
In Commercial Distribution
🇺🇸 United States
ManaMed
DI: 00810113681634
·
Model: ManaWater Sling
·
MANAMED INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ManaMed
- Primary DI
- 00810113681634
- Version / Model
- ManaWater Sling
- Catalog Number
- MWSLING01
- Company Name
- MANAMED INC
- Labeler DUNS
- 084042331
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-20
- Public Version
- 1
- Public Version Date
- 2022-06-28
- Public Version Status
- New
- Public Device Record Key
- 2e0a6fff-4a44-402f-92d4-8522dfb217aa
Device Description
The ManaWater Sling is a waterproof arm sling that is designed to be worn in the shower, bath, or water environment to help in the healing process for a variety of shoulder injuries and surgeries including: Dislocated Shoulder Rotator Cuff Repair Clavicle or Humerus Fracture Neuropathy Fractured Arm AC Separation Tendonitis Features & Benefits Immobilizes the arm and shoulder Low-profile and lightweight Water Safe Comfortable neck pad and adjustable wrist cuff Easy one-handed adjustments Leaves arm open Universal fit: Can be worn on right or left
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ILI | Sling, Arm | Physical Medicine | 890.3640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12101 | Shoulder immobilizer/orthosis, reusable | A prefabricated (non-customized) non-rigid wearable device designed to support, align, and/or temporarily immobilize the shoulder joint to support the healing of an injury or surgical wound. It will typically consist of straps, buckles, fasteners, or be in the form of a sling. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810113681634 | GS1 |
Customer Contacts
- Phone
- 888-508-0712
- [email protected]