FDA UDI
In Commercial Distribution
🇺🇸 United States
SURGIFOAM® Absorbable Gelatin Powder Kit
DI: 15712123000264
·
Model: 1979
·
Ferrosan Medical Devices A/S
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SURGIFOAM® Absorbable Gelatin Powder Kit
- Primary DI
- 15712123000264
- Version / Model
- 1979
- 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
- 2014-09-24
- Public Version
- 14
- Public Version Date
- 2023-08-14
- Public Version Status
- Update
- Public Device Record Key
- 101e7e3d-9847-4724-a23b-82c57327ccc1
Device Description
The kit is a convenient kit that includes SURGIFOAM® Absorbable Gelatin Powder, ref. 1978, with a syringe and an applicator tip.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 | 15712123000264 | GS1 | ||||
| Package | 25712123000261 | GS1 | Box | 6 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P990004 | 004 |
| P990004 | 036 |
| P990004 | 039 |
| P990004 | 041 |
| P990004 | 042 |
| P990004 | 047 |
| P990004 | 049 |
| P990004 | 051 |
| P990004 | 052 |
| P990004 | 054 |
| P990004 | 056 |
| P990004 | 058 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 1 | Gram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius