SURGIFLO™ Hemostatic Matrix Kit with Thrombin
- Primary DI
- 15712123000646
- Brand
- SURGIFLO™ Hemostatic Matrix Kit with Thrombin
- Company
- Ferrosan Medical Devices A/S
- Model
- SF2995
- Published
- 2026-01-05
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| LMF | Agent, Absorbable Hemostatic, Collagen Based |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery | 3 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| P990004 | 002 |
| P990004 | 008 |
| P990004 | 012 |
| P990004 | 016 |
| P990004 | 017 |
| P990004 | 018 |
| P990004 | 019 |
| P990004 | 022 |
| P990004 | 025 |
| P990004 | 028 |
| P990004 | 030 |
| P990004 | 031 |
| P990004 | 032 |
| P990004 | 033 |
| P990004 | 034 |
| P990004 | 036 |
| P990004 | 037 |
| P990004 | 038 |
| P990004 | 040 |
| P990004 | 041 |
| P990004 | 042 |
| P990004 | 043 |
| 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 |
| P990004 | 064 |
| P990004 | 067 |
| P990004 | 068 |
| P990004 | 069 |
| P990004 | 070 |
| P990004 | 073 |
| P990004 | 074 |
Premarket Details#
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| P990004 | 002 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 008 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 012 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 016 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 017 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 018 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 019 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 022 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 025 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 028 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 030 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 031 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 032 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 033 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 034 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 036 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 037 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 038 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 040 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 041 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 042 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 043 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 048 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 049 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 052 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 053 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 054 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 055 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 056 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 057 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 058 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 059 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 061 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 062 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 063 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 064 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 067 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 068 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 069 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 070 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 073 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
| P990004 | 074 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | 1999-09-30 | LMF |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 25712123000643 | Package | GS1 | 6 | In Commercial Distribution |
| 15712123000646 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 25712123000643 | 25712123000643 |
| 15712123000646 | 15712123000646 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 2 Degrees Celsius | 25 Degrees Celsius | |
| Storage Environment Temperature | 36 Degrees Fahrenheit | 77 Degrees Fahrenheit |
Regulatory Flags#
- DUNS number
- 305175344
- Device count
- 1
- Kit
- true
- Combination product
- true
- Lot or batch
- true
- Expiration date on label
- true
- No natural rubber latex
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 15712123000141 | SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. Oral Sponge | 1969 | 2014-09-20 | |
| 15712123000226 | SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. Hemorrhoidectomy Sponge | 1977 | 2014-09-20 | |
| 15712123000158 | SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. | 1972 | 2014-09-20 | |
| 15712123000172 | SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. | 1973 | 2014-09-20 | |
| 15712123000189 | SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. | 1974 | 2014-09-20 | |
| 15712123000202 | SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. | 1975 | 2014-09-20 | |
| 25712123000643 | SURGIFLO™ Hemostatic Matrix Kit with Thrombin | SF2995 | 2026-01-05 | |
| 15712123000288 | SURGIFLO® Hemostatic Matrix Kit with Thrombin | 2994 | 2016-05-10 | |
| 15712123000318 | SURGIFLO® Hemostatic Matrix | 2991 | 2014-09-20 | |
| 15712123000240 | SURGIFOAM® Absorbable Gelatin Powder | 1978 | 2014-09-20 | |
| 15712123000264 | SURGIFOAM® Absorbable Gelatin Powder Kit | 1979 | 2014-09-24 | |
| 15712123000325 | SURGIFLO® Hemostatic Matrix Kit with Thrombin | 2993 | 2014-09-20 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 25712123000643 | SURGIFLO™ Hemostatic Matrix Kit with Thrombin | Ferrosan Medical Devices A/S | LMF | 2026-01-05 |
| 00801741223105 | Avitene | Davol Inc. | LMF | 2023-06-27 |
| 10801741223102 | Avitene | Davol Inc. | LMF | 2023-06-27 |
| 10381780508656 | OraFOAM™ | Integra Lifesciences Corporation | LMF | 2019-02-04 |
| 00300092250018 | GEL-FLOW KIT | PHARMACIA & UPJOHN COMPANY LLC | LMF | 2018-08-17 |
| 00300091040016 | GEL-FLOW™ NT | PHARMACIA & UPJOHN COMPANY LLC | LMF | 2018-04-17 |
| 00300091040061 | GEL-FLOW™ NT | PFIZER INC. | LMF | 2018-04-17 |
| 00085412086309 | Gelfoam Plus | BAXTER HEALTHCARE CORPORATION | LMF | 2017-12-21 |
| 50085412086304 | Gelfoam Plus | BAXTER HEALTHCARE CORPORATION | LMF | 2017-12-21 |
| 00085412096100 | Floseal Hemostatic Matrix | BAXTER HEALTHCARE CORPORATION | LMF | 2017-10-09 |
| 00085412096124 | Floseal Hemostatic Matrix | BAXTER HEALTHCARE CORPORATION | LMF | 2017-10-09 |
| 50085412096105 | Floseal Hemostatic Matrix | BAXTER HEALTHCARE CORPORATION | LMF | 2017-10-09 |
| 00360793310107 | GELFOAM-JMI™ Sponge Kit | PHARMACIA & UPJOHN COMPANY LLC | LMF | 2017-06-05 |
| 00360793410104 | GELFOAM-JMI™ Powder Kit | PHARMACIA & UPJOHN COMPANY LLC | LMF | 2017-06-05 |
| 00085412095158 | Gelfoam Plus | BAXTER HEALTHCARE CORPORATION | LMF | 2016-09-08 |
| 00085412095165 | Gelfoam Plus | BAXTER HEALTHCARE CORPORATION | LMF | 2016-09-08 |
| 50085412095153 | Gelfoam Plus | BAXTER HEALTHCARE CORPORATION | LMF | 2016-09-08 |
| 50085412095160 | Gelfoam Plus | BAXTER HEALTHCARE CORPORATION | LMF | 2016-09-08 |
| 15712123000288 | SURGIFLO® Hemostatic Matrix Kit with Thrombin | Ferrosan Medical Devices A/S | LMF | 2016-05-10 |
| 00085412096094 | Floseal Hemostatic Matrix | BAXTER HEALTHCARE CORPORATION | LMF | 2015-05-22 |
| 00085412096117 | Floseal Hemostatic Matrix | BAXTER HEALTHCARE CORPORATION | LMF | 2015-05-22 |
| 00085412091006 | Floseal Special Applicator Tips | BAXTER HEALTHCARE CORPORATION | LMF | 2015-05-14 |
| 50085412091001 | Floseal Special Applicator Tips | BAXTER HEALTHCARE CORPORATION | LMF | 2015-05-14 |
| 00808232000801 | Vitagel | Stryker Orthobiologics | LMF | 2014-09-24 |
| 00808232000818 | Vitagel | Stryker Orthobiologics | LMF | 2014-09-24 |
| 00808232001242 | VitaPrep | Stryker Corporation | LMF | 2014-09-24 |
| 00808232001389 | Vitagel | Stryker Corporation | LMF | 2014-09-24 |
| 00808232001396 | Vitagel | Stryker Corporation | LMF | 2014-09-24 |
| 15712123000264 | SURGIFOAM® Absorbable Gelatin Powder Kit | Ferrosan Medical Devices A/S | LMF | 2014-09-24 |
| 30808232000802 | Vitagel | Stryker Orthobiologics | LMF | 2014-09-24 |