Identity
- Trade Name
- Cross-Seal FDA UDI
- Generic Name
- Polyolefin/fluoropolymer suture, monofilament FDA UDI
- Device Name
- The Cross-Seal Accessories (Cross-Seal Knot Tyer, Cross-Seal Knot Pusher, and Cross-Seal Suture Trimmer) are designed to tie the knots, position the knot to the top of the arteriotomy, and to trim the trailing limbs of the suture, respectively. FDA UDI
- Model / Reference
- 002 FDA UDI
- Description
- The Cross-Seal Accessories (Cross-Seal Knot Tyer, Cross-Seal Knot Pusher, and Cross-Seal Suture Trimmer) are designed to tie the knots, position the knot to the top of the arteriotomy, and to trim the trailing limbs of the suture, respectively. FDA UDI
Identifiers
- Catalog Number
- 002 FDA UDI
- Primary DI / UDI-DI
- 04719872920380 FDA UDI
- FDA Product Code
- MGB FDA UDI
- GMDN Term
- Polyolefin/fluoropolymer suture, monofilament FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Polyolefin/fluoropolymer suture, monofilament
Cross-Seal by Medeon Biodesign, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Medeon Biodesign, Inc.
Sources (1)
- FDA UDI 4f557e50-b039-4053-9a04-fa0834ce73e2 34 fields · synced Jun 1, 2026