FDA UDI
In Commercial Distribution
🇺🇸 United States
ENDURE INDUSTRIES
DI: 00840118612791
·
Model: A2001
·
ENDURE INDUSTRIES
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ENDURE INDUSTRIES
- Primary DI
- 00840118612791
- Version / Model
- A2001
- Catalog Number
- A2001
- Company Name
- ENDURE INDUSTRIES
- Labeler DUNS
- 066087031
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-15
- Public Version
- 1
- Public Version Date
- 2023-10-23
- Public Version Status
- New
- Public Device Record Key
- 6d5fde55-5370-45d9-a07f-b9f91227cf11
Device Description
Compressed Gauze, Sterile Crinkle Cotton Fluff Bandage Roll 4.5" x 4.1 yards
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
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FQM | Bandage, Elastic | General Hospital | 880.5075 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48127 | Woven gauze roll/sheet | A device in the form of a long length of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, and injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840118612791 | GS1 |
Customer Contacts
- Phone
- +1 607-299-4971
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 49 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 49 Degrees Celsius