FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SURGIFLO® Hemostatic Matrix Kit with Thrombin
DI: 15712123000325
·
Model: 2993
·
Ferrosan Medical Devices A/S
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SURGIFLO® Hemostatic Matrix Kit with Thrombin
- Primary DI
- 15712123000325
- Version / Model
- 2993
- Company Name
- Ferrosan Medical Devices A/S
- Labeler DUNS
- 305175344
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-20
- Public Version
- 4
- Public Version Date
- 2018-08-08
- Public Version Status
- Update
- Public Device Record Key
- 963cec92-60d4-4dfd-99ae-8216d5262e64
- Distribution End Date
- 2017-11-30
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 |
|---|---|---|---|---|
| LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery | 878.4490 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48170 | Gelatin haemostatic agent | A sterile, bioabsorbable device derived from animal gelatin (typically pork skin gelatin) that is intended to be applied to surgical and traumatic wounds to facilitate local haemostasis through its high blood-absorbing capacity; it does not contain an antimicrobial agent. It is typically in the form of a pad/sponge and has no intrinsic haemostatic action but induces haemostasis through its intensely porous structure which enables it to absorb many times its weight in blood; the device is intended to remain in the wound to be absorbed by the body. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15712123000325 | GS1 | ||||
| Package | 25712123000322 | GS1 | Box | 6 | Not in Commercial Distribution | 2017-11-30 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P990004 | 008 |
| P990004 | 016 |
| P990004 | 017 |
| P990004 | 018 |
| P990004 | 019 |
| P990004 | 022 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 77 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius