Identity
- Trade Name
- MONOSWIFT FDA UDI
- Generic Name
- Polyglyconate suture FDA UDI
- Model / Reference
- L399 FDA UDI
Identifiers
- Catalog Number
- L399 FDA UDI
- Primary DI / UDI-DI
- 10790986001654 FDA UDI
- 510(k) Number
- K072229 FDA UDI
- FDA Product Code
- GAM FDA UDI
- GMDN Term
- Polyglyconate suture FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4493 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Polyglyconate suture
Monoswift by Cp Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyglyconate suture.
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- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Mckesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
Cleared under the same submission
K072229 also covers:
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 |
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Manufacturer
- Manufacturer
- Cp Medical
Sources (1)
- FDA UDI 0a618969-4ef7-471b-b415-cecf9124b8ba 34 fields · synced May 30, 2026