FDA UDI
In Commercial Distribution
🇺🇸 United States
ETHIZIA
DI: 10705031471214
·
Model: HSP510
·
Ethicon Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- ETHIZIA
- Primary DI
- 10705031471214
- Version / Model
- HSP510
- Catalog Number
- HSP510
- Company Name
- Ethicon Inc.
- Labeler DUNS
- 002144145
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-16
- Public Version
- 1
- Public Version Date
- 2026-01-26
- Public Version Status
- New
- Public Device Record Key
- 22a660a7-2473-43dd-b1bc-20fb166ea822
Device Description
Hemostatic Patch
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- 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 |
|---|---|---|---|---|
| SGV | Agent, absorbable hemostatic, collagen with polymeric additives | General, Plastic Surgery | 878.4490 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67026 | Gelatin/inorganic composite haemostatic agent | A bioabsorbable device made of animal gelatin (typically pork skin gelatin) and synthetic polymer materials that is intended to be applied to surgical and traumatic wounds to facilitate local haemostasis through its tamponade effect and formation of a mechanical barrier; it does not contain an antimicrobial agent. It is typically in the form of a pad/sponge/patch and has no intrinsic haemostatic action but induces haemostasis by facilitating the coagulation process by creating a matrix for platelet aggregation and fibrin formation; 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 |
|---|---|---|---|---|---|---|
| Package | 30705031471218 | GS1 | CASE | 10 | In Commercial Distribution | |
| Primary | 10705031471214 | GS1 |
Customer Contacts
- Phone
- +1(877)384-4266
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 41 – 77 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 25 Degrees Celsius