FDA UDI
In Commercial Distribution
🇺🇸 United States
SURGIFLO® Hemostatic Matrix Kit with Thrombin
DI: 15712123000288
·
Model: 2994
·
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
- 15712123000288
- Version / Model
- 2994
- Company Name
- Ferrosan Medical Devices A/S
- Labeler DUNS
- 305175344
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-05-10
- Public Version
- 18
- Public Version Date
- 2023-10-31
- Public Version Status
- Update
- Public Device Record Key
- 32dca4fd-8ce7-466e-b9c1-0492bd28317e
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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 | 15712123000288 | GS1 | ||||
| Package | 25712123000285 | GS1 | Box | 6 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P990004 | 008 |
| P990004 | 016 |
| P990004 | 017 |
| P990004 | 018 |
| P990004 | 019 |
| P990004 | 022 |
| P990004 | 025 |
| P990004 | 028 |
| P990004 | 030 |
| P990004 | 031 |
| P990004 | 033 |
| P990004 | 034 |
| P990004 | 035 |
| P990004 | 036 |
| P990004 | 037 |
| P990004 | 038 |
| P990004 | 040 |
| P990004 | 041 |
| P990004 | 042 |
| P990004 | 043 |
| P990004 | 044 |
| P990004 | 045 |
| P990004 | 048 |
| P990004 | 049 |
| P990004 | 052 |
| P990004 | 053 |
| P990004 | 054 |
| P990004 | 055 |
| P990004 | 056 |
| P990004 | 057 |
| P990004 | 058 |
| P990004 | 059 |
| P990004 | 061 |
| P990004 | 062 |
| P990004 | 063 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 77 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius