FDA UDI
In Commercial Distribution
🇺🇸 United States
FLOSEAL HEMOSTATIC MATRIX
DI: 00085412656304
·
Model: ADS201883
·
BAXTER HEALTHCARE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- FLOSEAL HEMOSTATIC MATRIX
- Primary DI
- 00085412656304
- Version / Model
- ADS201883
- Catalog Number
- ADS201883
- Company Name
- BAXTER HEALTHCARE CORPORATION
- Labeler DUNS
- 628013963
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-31
- Public Version
- 7
- Public Version Date
- 2023-08-10
- Public Version Status
- Update
- Public Device Record Key
- 50bb92ba-a4cf-4166-848d-839427ce9717
Device Description
Floseal Matrix is indicated in surgical procedures (other than in ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
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 | 50085412656309 | GS1 | CASE | 6 | In Commercial Distribution | |
| Primary | 00085412656304 | GS1 |
Customer Contacts
- Phone
- +1(888)229-0001
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P990009 | 053 |
| P990009 | 061 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 5 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not freeze. Keep dry and away from sunlight.
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius