Identity
- Trade Name
- PDO Max Threads FDA UDI
- Generic Name
- Polyester suture, bioabsorbable, monofilament, non-antimicrobial FDA UDI
- Device Name
- Levo 18gx100mm Sterile Inner FDA UDI
- Model / Reference
- PM18100L-FE-BP FDA UDI
- Description
- Levo 18gx100mm Sterile Inner FDA UDI
Identifiers
- Catalog Number
- PM18100L-FE-BP FDA UDI
- Primary DI / UDI-DI
- 00850018324052 FDA UDI
- 510(k) Number
- K190245 FDA UDI
- FDA Product Code
- NEW FDA UDI
- GMDN Term
- Polyester suture, bioabsorbable, monofilament, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4840 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
No
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
Yes
FDA UDI
Category: Polyester suture, bioabsorbable, monofilament, non-antimicrobial
PDO Max Threads by Max Pdo Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyester suture, bioabsorbable, monofilament, non-antimicrobial.
- Monoswift — RIVERPOINT MEDICAL LLC · Class II
- DemeDIOX — DemeTECH Corp · Class II
- DemeCAPRONE — DemeTECH Corp · Class II
- DemeCAPRONE — DemeTECH Corp · Class II
- WEGO-PDO Absorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc. · Class II
- Maxon — Covidien LP · Class II
- DemeCAPRONE — DemeTECH Corp · Class II
- DemeCAPRONE — DemeTECH Corp · Class II
Cleared under the same submission
K190245 also covers:
- PDO Max Threads — Max Pdo Inc
- PDO Max Threads — Max Pdo Inc
- PDO Max Threads — Max Pdo Inc
- PDO Max Threads — Max Pdo Inc
- PDO Max Threads — Max Pdo Inc
- PDO Max Threads — Max Pdo Inc
- PDO Max Threads — Max Pdo Inc
- PDO Max Threads — Max Pdo Inc
- PDO Max Threads — Max Pdo Inc
- PDO Max Threads — Max Pdo Inc
- PDO Max Threads — Max Pdo Inc
- PDO Max Threads — Max Pdo Inc
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Max Pdo Inc
Sources (1)
- FDA UDI 35d9e994-d766-4f48-931a-1b7d8b7069f4 35 fields · synced May 30, 2026