FDA UDI
In Commercial Distribution
🇺🇸 United States
Hemopore
DI: 07613327500486
·
Model: 5400222208S
·
STRYKER CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Hemopore
- Primary DI
- 07613327500486
- Version / Model
- 5400222208S
- Catalog Number
- 5400-222-208S
- Company Name
- STRYKER CORPORATION
- Labeler DUNS
- 196548481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-08
- Public Version
- 1
- Public Version Date
- 2020-01-16
- Public Version Status
- New
- Public Device Record Key
- e5788d0d-8f93-4ca9-8962-a9adbf74e93e
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| LYA | SPLINT, INTRANASAL SEPTAL | Ear, Nose, Throat | 874.4780 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44434 | ENT space-occupying dressing, animal-derived | A sterile, bioabsorbable material intended to be used to help heal tissue, limit adhesions between mucosal surfaces, and control bleeding after ear/nose/throat (ENT) surgery or trauma. It is typically available as a gel or gelatin sponge; it contains animal-derived components (e.g., collagen), and may additionally contain microbe-derived (biosynthetic) components [e.g., hyaluronic acid (HA)]. In nasal/sinus applications it may be aspirated (removed) from the cavity before absorption. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 37613327500487 | GS1 | pack | 2 | In Commercial Distribution | |
| Primary | 07613327500486 | GS1 |
Customer Contacts
- Phone
- +1(800)253-3210
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 8 Degrees Celsius