FDA UDI
In Commercial Distribution
🇺🇸 United States
Avitene Ultrafoam
DI: 00801741010538
·
Model: 1050030
·
Davol Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Avitene Ultrafoam
- Primary DI
- 00801741010538
- Version / Model
- 1050030
- Catalog Number
- 1050030
- Company Name
- Davol Inc.
- Labeler DUNS
- 001191048
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-12
- Public Version
- 4
- Public Version Date
- 2020-06-19
- Public Version Status
- Update
- Public Device Record Key
- f54ee5b3-3c83-4c8d-be52-469dbec5af2a
Device Description
Avitene Ultrafoam Collagen Hemostat
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
- 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 |
|---|---|---|---|---|
| 47201 | Collagen haemostatic agent, non-antimicrobial | A bioabsorbable device derived from animal collagen (e.g., bovine or porcine collagen) designed to produce a rapid haemostasis through platelet activation/aggregation (which initiates the haemostatic cascade leading to a fibrin clot) during a surgical procedure. It is applied directly to the wound where it remains to be absorbed by the body; it is not dedicated to a specific anatomy/application and does not contain an antimicrobial agent. It may be supplied as a fibrillar or soft, pliable pad/sponge or loose fibres; it may be applied in combination with fibrin adhesives. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10801741010535 | GS1 | CA | 6 | In Commercial Distribution | |
| Primary | 00801741010538 | GS1 |
Customer Contacts
- Phone
- +1(800)562-0027
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| N17600 | 016 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 8 | Centimeter | |
| Length | 6.25 | Centimeter | |
| Depth | 1 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 70 Degrees Celsius