FDA UDI
In Commercial Distribution
🇺🇸 United States
Arm Sling
DI: 00616784435114
·
Model: 4351
·
DYNAREX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Arm Sling
- Primary DI
- 00616784435114
- Version / Model
- 4351
- Company Name
- DYNAREX CORPORATION
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-01
- Public Version
- 1
- Public Version Date
- 2021-09-09
- Public Version Status
- New
- Public Device Record Key
- ae4ce5c2-82c0-48dc-bd3c-78ac440e9979
Device Description
Arm Sling- Universal, Blue, 19"x8"
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 13622 | Suspension arm sling | A non-sterile hanging triangular-shaped loop, suspended from a patient's neck/shoulder, typically intended to support an injured arm and limit its range of motion, or immobilize it, during the period of healing. It is typically fashioned from a single sheet of textile material by tying/fastening the ends. This is a reusable device intended for single-patient use. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00616784435121 | GS1 | Box | 6 | In Commercial Distribution | |
| Primary | 00616784435114 | GS1 | ||||
| Package | 00616784435138 | GS1 | Case | 6 | In Commercial Distribution |