FDA UDI
In Commercial Distribution
🇺🇸 United States
MECRON Belt B: 29 cm, U: 66-86 cm
DI: 00609271950146
·
Model: 38-7420
·
DARCO INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MECRON Belt B: 29 cm, U: 66-86 cm
- Primary DI
- 00609271950146
- Version / Model
- 38-7420
- Catalog Number
- 38-7420
- Company Name
- DARCO INTERNATIONAL, INC.
- Labeler DUNS
- 184231298
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-14
- Public Version
- 1
- Public Version Date
- 2023-02-22
- Public Version Status
- New
- Public Device Record Key
- b6314745-6b38-4887-9fd3-078dbe2233f2
Device Description
S White 4-tape bandage
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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 |
|---|---|---|---|---|
| IPX | ORTHOSIS, RIB FRACTURE, SOFT | Physical Medicine | 890.3490 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47217 | Abdominal binder, reusable | A strip, roll or tube of fabric or polymer material intended to be applied to the abdomen to support relaxed abdominal walls (e.g., after surgery, during pregnancy) or to provide support for another device (e.g., dressing, ultrasound transducer, percutaneous lead). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10609271950143 | GS1 | Box | 12 | In Commercial Distribution | |
| Primary | 00609271950146 | GS1 |