Identity
- Trade Name
- Lac-Mac FDA UDI
- Generic Name
- Surgical gown, reusable FDA UDI
- Device Name
- Surgical Gown, Level 4, custom color code, grips on knit neckband, customer barcode, RF chip, patented Size XL FDA UDI
- Model / Reference
- 005XEAG-XL FDA UDI
- Description
- Surgical Gown, Level 4, custom color code, grips on knit neckband, customer barcode, RF chip, patented Size XL FDA UDI
Identifiers
- Catalog Number
- 005XEAG-XL FDA UDI
- Primary DI / UDI-DI
- 00627755055057 FDA UDI
- 510(k) Number
- K061491 FDA UDI
- FDA Product Code
- FYA FDA UDI
- GMDN Term
- Surgical gown, reusable 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
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Height — 56.25 Inch FDA UDIWidth — 27 Inch FDA UDI
Category: Surgical gown, reusable
Lac-Mac by Lac Mac, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Lac Mac, Ltd.
Sources (1)
- FDA UDI ff30027d-b2a1-4c09-be81-8a9a9a9c6d81 37 fields · synced May 30, 2026