Identity
- Trade Name
- MEDLINE FDA UDI
- Generic Name
- Surgical gown, single-use FDA UDI
- Device Name
- GOWN,NON-REINFORCED,SIRUS,SET IN SLV FDA UDI
- Model / Reference
- DYNJP2002SG FDA UDI
- Description
- GOWN,NON-REINFORCED,SIRUS,SET IN SLV FDA UDI
Identifiers
- Catalog Number
- DYNJP2002SG FDA UDI
- Primary DI / UDI-DI
- 10888277678729 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical gown, single-use
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical gown, single-use.
- Halyard — O&M HALYARD, INC. · Class II
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- Reinforce Surgical Gown (AAMI Level 3) — Foshan Nanhai Plus Medical Co., Ltd · Class II
- Beaver Visitec Inter — GRI Medical & Electronic Technology Co., Ltd. · Class II
- T7 — Stryker Corp. · Class II
- StringKing — String King Lacrosse, LLC · Class II
- Disposable Surgical Gowns — Weihai Hongyu Nonwoven Fabric Products Co., Ltd. · Class II
- Halyard — O&M HALYARD, INC. · Class II
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
- Medline Industries, Inc.
Sources (1)
- FDA UDI f5e53018-5da7-4702-bead-a2e214cd746f 35 fields · synced Jun 8, 2026