FDA UDI
In Commercial Distribution
🇺🇸 United States
GD
DI: 00850699008128
·
Model: 101830UW
·
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
- 00850699008128
- Version / Model
- 101830UW
- Catalog Number
- 101830UW
- 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
- 2022-12-04
- Public Version
- 1
- Public Version Date
- 2022-12-12
- Public Version Status
- New
- Public Device Record Key
- a63947b0-7f1b-4643-b98b-04441ca87ce8
Device Description
Green Reusable Towels Bulk Non-sterile
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 |
|---|---|---|---|---|
| PUI | Drape, Surgical, Exempt | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14077 | Surgical towel | A sterile cloth used in the operating room (OR) to absorb extraneous fluids. 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 | 00850699008876 | GS1 | ||||
| Primary | 00850699008128 | GS1 |
Customer Contacts
- Phone
- 630.842.6595
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 100 Degrees Fahrenheit