FDA UDI
In Commercial Distribution
🇺🇸 United States
Stretch Gauze Bandage Roll, Non-Sterile
DI: 00616784313238
·
Model: 3132
·
DYNAREX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
500
Basic Information
- Brand Name
- Stretch Gauze Bandage Roll, Non-Sterile
- Primary DI
- 00616784313238
- Version / Model
- 3132
- Company Name
- DYNAREX CORPORATION
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2021-06-21
- Public Version
- 1
- Public Version Date
- 2021-06-29
- Public Version Status
- New
- Public Device Record Key
- f298b896-9a9a-4eac-91b2-ae67dfda1804
Device Description
Stretch Gauze Bandage Roll, Non-Sterile, Individually Wrapped, 2"x4.1yd
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
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| FQM | Bandage, Elastic | General Hospital | 880.5075 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48126 | Woven gauze roll, non-sterile | A non-sterile device in the form of a long strip of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00616784313221 | GS1 | ||||
| Primary | 00616784313238 | GS1 |