FDA UDI
In Commercial Distribution
🇺🇸 United States
Biotronik Neptune
DI: 00811331011463
·
Model: 8870-02
·
Tz Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Biotronik Neptune
- Primary DI
- 00811331011463
- Version / Model
- 8870-02
- Company Name
- Tz Medical, Inc.
- Labeler DUNS
- 793149709
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2023-10-16
- Public Version
- 1
- Public Version Date
- 2023-10-24
- Public Version Status
- New
- Public Device Record Key
- bc1e11c7-6c60-413e-b932-a0b12d3eb3fa
Device Description
Biotronik Neptune Pad
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| FRO | Dressing, Wound, Drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34084 | Wound compression dressing | A sterile covering designed to exert pressure on a wounded area to prevent the collection of fluids in the underlying tissues; most commonly used after skin grafting and in the treatment of burns. 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 | 00811331011456 | GS1 | ||||
| Primary | 00811331011463 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K040208 | 000 |