FDA UDI
In Commercial Distribution
🇺🇸 United States
FloraSeal
DI: M495FS250D1
·
Model: FS250D
·
ADHEZION BIOMEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
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Basic Information
- Brand Name
- FloraSeal
- Primary DI
- M495FS250D1
- Version / Model
- FS250D
- Catalog Number
- FS-250D
- Company Name
- ADHEZION BIOMEDICAL, LLC
- Labeler DUNS
- 827716437
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2016-11-21
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 243993ac-0edf-4ecc-87dd-817e6842fc70
Device Description
FloraSeal Microbial Sealant
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- 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 |
|---|---|---|---|---|
| NZP | Sealant, Microbial | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46700 | Surgical skin microbial sealant | A sterile synthetic substance (e.g., cyanoacrylate) intended to be applied to the skin of a patient prior to surgical incision (typically over commonly used preoperative skin preparation and with or without standard surgical draping) to, upon polymerization, bond to the skin and fix microbes, reducing the risk of skin flora contamination during the surgical procedure. It is typically contained within a disposable, ready-to-use applicator. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M495FS250D1 | HIBCC | ||||
| Unit of Use | M495FS250D0 | HIBCC |
Customer Contacts
- Phone
- 8287263791
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K083354 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 2.5 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 86 Degrees Fahrenheit