Identity
- Trade Name
- Rospital Productos Medicos FDA UDI
- Generic Name
- Surgical gown, single-use FDA UDI
- Device Name
- SURGEON'S GOWN, EXTRA LARGE, KNITTED CUFF WITH 2 PIECE HAND TOWEL & WRAP - 1 EA/POUCH FDA UDI
- Model / Reference
- SUSSG003 FDA UDI
- Description
- SURGEON'S GOWN, EXTRA LARGE, KNITTED CUFF WITH 2 PIECE HAND TOWEL & WRAP - 1 EA/POUCH FDA UDI
Identifiers
- Catalog Number
- SUSSG003 FDA UDI
- Primary DI / UDI-DI
- 00812460028094 FDA UDI
- 510(k) Number
- K173847 FDA UDI
- FDA Product Code
- FYA FDA UDI
- GMDN Term
- Surgical gown, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4040 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
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
No
FDA UDI
Category: Surgical gown, single-use
Rospital Productos Medicos by Atlas Medical Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K173847 also covers:
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Disposable Ultra Reinforced Surgical Gown — Hubei Medlink Healthcare Co., Ltd.
- Disposable Ultra Reinforced Surgical Gown — Hubei Medlink Healthcare Co., Ltd.
- Disposable ultra Reinforced Surgical Gown — Hubei Medlink Healthcare Co., Ltd.
- Disposable ultra Reinforced Surgical Gown — Hubei Medlink Healthcare Co., Ltd.
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
- Atlas Medical Products Llc
Sources (1)
- FDA UDI 3627276a-a633-4137-8887-d22f16bc9111 37 fields · synced May 30, 2026