FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Dale Strapless Bendable Armboard
DI: 00817612020971
·
Model: 550
·
DALE MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Dale Strapless Bendable Armboard
- Primary DI
- 00817612020971
- Version / Model
- 550
- Catalog Number
- 550
- Company Name
- DALE MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 001061233
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-14
- Public Version
- 2
- Public Version Date
- 2023-05-10
- Public Version Status
- Update
- Public Device Record Key
- d9b07ff9-31b3-4ca0-b15e-6665d35bdfcd
- Distribution End Date
- 2022-07-28
Device Description
Dale Strapless Bendable Armboard, Large, 9" x 3.5"
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FYH | Splint, Extremity, Noninflatable, External, Sterile | General, Plastic Surgery | 878.3910 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61139 | Arm procedure positioner, single-use | A device designed to support and stabilize a patient's arm in a desired position during a medical procedure [e.g., to maintain the patency of an intravenous (IV) needle or an intravascular catheter]. Also known as an arm posturing device or armboard, it is typically constructed as an elongated, curved, cushioned surface, and may be attached or fixed (e.g., onto a side rail). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00817612020964 | GS1 | Box | 10 | Not in Commercial Distribution | 2022-07-28 |
| Primary | 00817612020971 | GS1 |