FDA UDI
In Commercial Distribution
🇺🇸 United States
PSD gel
DI: 00085412531434
·
Model: PSDGEL3PKWTIPS
·
SYNOVIS LIFE TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PSD gel
- Primary DI
- 00085412531434
- Version / Model
- PSDGEL3PKWTIPS
- Catalog Number
- PSDGel3pkwTips
- Company Name
- SYNOVIS LIFE TECHNOLOGIES, INC.
- Labeler DUNS
- 017415781
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-05
- Public Version
- 5
- Public Version Date
- 2023-10-30
- Public Version Status
- Update
- Public Device Record Key
- a8cecb0e-4f69-43d8-901f-c5a34c7cd245
Device Description
PSD Gel is prepared from Hydroxypropyl Methyl Cellulose, Propylene Glycol, and water. The PSD Gel is used to bond the Peri-Strips Dry pericardium strips onto the surgical stapler forks until the stapler is positioned and fired.
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
- Yes
- 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 |
|---|---|---|---|---|
| FTM | Mesh, surgical | General, Plastic Surgery | 878.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58268 | Staple line-reinforcement strip gel | A sterile gelatinous substance designed to be used during staple line buttress (reinforcement) procedures (e.g., lung/bronchus resections, bariatric and small bowel surgery). It is typically applied to the buttress strip material to facilitate rehydration and temporary adherence to the surgical stapler unit prior to the application of the staples and buttress strip to body tissue. It typically consists of a colloidal suspension (hydrogel) applied with an included applicator. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50085412531439 | GS1 | CASE | 3 | In Commercial Distribution | |
| Primary | 00085412531434 | GS1 |
Customer Contacts
- Phone
- +1(800)933-0303
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius