Identity
- Trade Name
- Argyle FDA UDI
- Generic Name
- Peritoneal catheter stylet FDA UDI
- Device Name
- Peritoneal Dialysis Accessory Catheter Straightening Stylet FDA UDI
- Model / Reference
- 8888415646 FDA UDI
- Description
- Peritoneal Dialysis Accessory Catheter Straightening Stylet FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521004764 FDA UDI
- 510(k) Number
- K920515 FDA UDI
- FDA Product Code
- FJS FDA UDI
- GMDN Term
- Peritoneal catheter stylet FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ultraviolet Light FDA UDI
Dimensions & Sizes
- Size
- Length — 44.5 Centimeter FDA UDI
Category: Peritoneal catheter stylet
Argyle by Mozarc Medical US LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peritoneal catheter stylet.
- Peritoneal Dialysis — Merit Medical Systems, Inc. · Class II
- Peritoneal Dialysis — Merit Medical Systems, Inc. · Class II
- Peritoneal Dialysis — Merit Medical Systems, Inc. · Class II
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- Guardia — COOK INCORPORATED · Class II
Cleared under the same submission
K920515 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
- Mozarc Medical US LLC
Sources (1)
- FDA UDI 83a75ba5-a02e-4102-8a4d-045e156b184e 36 fields · synced Jun 8, 2026