FDA UDI
In Commercial Distribution
🇺🇸 United States
Barbell Loop Ostomy Device
DI: 00860002701356
·
Model: BAR-4
·
TOOLS FOR SURGERY, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Barbell Loop Ostomy Device
- Primary DI
- 00860002701356
- Version / Model
- BAR-4
- Catalog Number
- BAR-4
- Company Name
- TOOLS FOR SURGERY, LLC
- Labeler DUNS
- 841842441
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-17
- Public Version
- 1
- Public Version Date
- 2023-07-25
- Public Version Status
- New
- Public Device Record Key
- 2959821f-d264-4a7e-9b4f-e3a878c50cf5
Device Description
Loop Ostomy Device, Large (4-inch rod).
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EZP | Rod, Colostomy | Gastroenterology, Urology | 876.4270 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31987 | Colostomy rod | A device that is placed through a loop of colon brought out through the abdominal wall to temporarily keep it from sliping back through the surgical opening during the loop colostomy procedure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860002701356 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 4 | Inch |