FDA UDI
In Commercial Distribution
🇺🇸 United States
Master
DI: 06975374671214
·
Model: gel
·
Dongguan Maisite Medical Instruments Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Master
- Primary DI
- 06975374671214
- Version / Model
- gel
- Company Name
- Dongguan Maisite Medical Instruments Co., Ltd.
- Labeler DUNS
- 711262474
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-12
- Public Version
- 1
- Public Version Date
- 2023-05-22
- Public Version Status
- New
- Public Device Record Key
- 6744447d-12a5-4568-82e8-5c71e9257fe8
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | 878.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56316 | Emphysematous lung sealant | A sterile fluid material intended to be introduced into the alveoli and bronchioles of targeted emphysematous lung subsegments where it gels to permanently seal the spaces and create a localized, post-obstructive atelectasis (airless/collapsed lung) as a therapeutic measure for a patient with advanced emphysema. It is typically administered by a pulmonologist or a thoracic surgeon as a liquid foam through a bronchoscopic catheter. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06975374671214 | GS1 |