DEROYAL INDUSTRIES, INC.

Entity profile compiled from public source records

Public Record Profile Registrations: 12 510(k) filings: 1 Recalls: 0

Known Identifiers & Locations

FEI Numbers 1000112877, 1000112968, 1000208576, 1000208624, 1034876, 1043214, 1051550, 3003040625, 3004605321, 3008583452, 3010452421, 3021190810
Owner Operator Numbers 1044833
Locations Covered MAYNARDVILLE, TN, US; NEW TAZEWELL, TN, US; POWELL, TN, US; Powell, TN, US; SANTIAGO, DO; Villa Canales Guatemala, GT

Registered Establishments (12)

Registration # Establishment Name Location Establishment Type(s) Action
1034876 DEROYAL INDUSTRIES, INC. MAYNARDVILLE, TN, US Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
1043214 DEROYAL INDUSTRIES, INC. POWELL, TN, US Complaint File Establishment per 21 CFR 820.198 View Details
1051550 DEROYAL INDUSTRIES, INC. MAYNARDVILLE, TN, US Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
1054241 DeRoyal Industries, Inc. NEW TAZEWELL, TN, US Sterilize Medical Device for Another Party (Contract Sterilizer) View Details
1055236 DEROYAL INDUSTRIES, INC. NEW TAZEWELL, TN, US Sterilize Medical Device for Another Party (Contract Sterilizer) View Details
1057404 DeRoyal Industries, Inc. POWELL, TN, US Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
1060680 DeRoyal Industries, Inc. NEW TAZEWELL, TN, US Repack or Relabel Medical Device View Details
2320762 DEROYAL INDUSTRIES, INC. NEW TAZEWELL, TN, US Repack or Relabel Medical Device View Details
3004605321 DEROYAL INTERCONTINENTAL, S.R.L. SANTIAGO, DO Repack or Relabel Medical Device View Details
3008583452 DeRoyal Industries, Inc. Powell, TN, US Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3010452421 Ortho and Surgical Products Enterprises S.A. Villa Canales Guatemala, GT Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3021190810 DePre, LLC Powell, TN, US Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device View Details

510(k) Premarket Notifications (1)

Submission # Device Name Decision Date Decision Description Action
K914369 QUALTEX MAGNETIC INSTRUMENT DRAPE 1991-12-02 Substantially Equivalent View Details

FDA Recall History (0)

No recall records found for this entity.

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