FDA UDI
In Commercial Distribution
🇺🇸 United States
GD
DI: 10850699008569
·
Model: 511-006
·
Jiangsu Guangda Medical Material Group Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
400
Basic Information
- Brand Name
- GD
- Primary DI
- 10850699008569
- Version / Model
- 511-006
- Catalog Number
- 511-006
- Company Name
- Jiangsu Guangda Medical Material Group Co.,Ltd.
- Labeler DUNS
- 421295761
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 400
- Record Status
- Published
- Publish Date
- 2022-12-05
- Public Version
- 2
- Public Version Date
- 2023-04-04
- Public Version Status
- Update
- Public Device Record Key
- 0f4741ff-639f-4bd0-9050-79d2b10daea2
Device Description
Non-sterile Fluftex Gauze Roll, Lg 400Cs
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAB | Gauze / Sponge,Nonresorbable For External Use | General, Plastic Surgery | 878.4014 | 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00850699008562 | GS1 | ||||
| Primary | 10850699008569 | GS1 |
Customer Contacts
- Phone
- 630.842.6595
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 100 Degrees Fahrenheit