FDA UDI
In Commercial Distribution
🇺🇸 United States
FLOSEAL HEMOSTATIC MATRIX
DI: 00085412827896
·
Model: ADS202110
·
BAXTER HEALTHCARE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- FLOSEAL HEMOSTATIC MATRIX
- Primary DI
- 00085412827896
- Version / Model
- ADS202110
- Catalog Number
- ADS202110
- Company Name
- BAXTER HEALTHCARE CORPORATION
- Labeler DUNS
- 628013963
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-09
- Public Version
- 1
- Public Version Date
- 2023-05-17
- Public Version Status
- New
- Public Device Record Key
- 9f7d0317-01db-4493-8e73-7979a1584970
Device Description
Floseal with Recothrom - 10mL.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| PMX | Absorbable collagen hemostatic agent with thrombin | General, Plastic Surgery | 878.4490 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47201 | Collagen haemostatic agent, non-antimicrobial | A bioabsorbable device derived from animal collagen (e.g., bovine or porcine collagen) designed to produce a rapid haemostasis through platelet activation/aggregation (which initiates the haemostatic cascade leading to a fibrin clot) during a surgical procedure. It is applied directly to the wound where it remains to be absorbed by the body; it is not dedicated to a specific anatomy/application and does not contain an antimicrobial agent. It may be supplied as a fibrillar or soft, pliable pad/sponge or loose fibres; it may be applied in combination with fibrin adhesives. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50085412827891 | GS1 | CA | 6 | In Commercial Distribution | |
| Primary | 00085412827896 | GS1 |
Customer Contacts
- Phone
- +1(888)229-0001
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P990009 | 070 |