FDA UDI
In Commercial Distribution
🇺🇸 United States
XenoSure Biologic Pledgets
DI: 00840663109357
·
Model: PL0510R25
·
Lemaitre Vascular, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- XenoSure Biologic Pledgets
- Primary DI
- 00840663109357
- Version / Model
- PL0510R25
- Catalog Number
- PL0510R25
- Company Name
- Lemaitre Vascular, Inc.
- Labeler DUNS
- 184805166
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-18
- Public Version
- 1
- Public Version Date
- 2021-06-28
- Public Version Status
- New
- Public Device Record Key
- ca9853f2-ce2a-476a-95f6-b9a59a57586b
Device Description
XenoSure Biologic Pledgets, 0.5cm x 1.0cm
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 |
|---|---|---|---|---|
| 35273 | Cardiovascular patch, animal-derived | An implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a patch made of, or coated/impregnated with, materials of animal origin (e.g., porcine, bovine, or equine pericardium/collagen), that is typically implanted with sutures. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840663109357 | GS1 |
Customer Contacts
- Phone
- 781-221-2266
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K040835 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius