FDA UDI
In Commercial Distribution
🇺🇸 United States
Curaplex
DI: 00817617027630
·
Model: 1124-32400
·
BOUND TREE MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Curaplex
- Primary DI
- 00817617027630
- Version / Model
- 1124-32400
- Catalog Number
- 1124-32400
- Company Name
- BOUND TREE MEDICAL, LLC
- Labeler DUNS
- 070556204
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-30
- Public Version
- 1
- Public Version Date
- 2023-04-07
- Public Version Status
- New
- Public Device Record Key
- 07ff1c44-2a0c-4d1e-8d61-91720b0b0100
Device Description
Curaplex Triangular Bandage, Muslin 12/pk 20pk/cs 40 in x 40 in x 56 in, 2 safety pins
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
- 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
- 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 |
|---|---|---|---|---|
| 12095 | Arm immobilizer | A non-rigid device, usually made of a fabric, used to temporarily render the arm immovable, typically at the shoulder and elbow, to support healing of an injury or a surgical wound. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00817617027616 | GS1 | Case | 20 | In Commercial Distribution | |
| Package | 00817617027623 | GS1 | Bag | 12 | In Commercial Distribution | |
| Primary | 00817617027630 | GS1 |