REMINGTON MEDICAL, INC.

Entity profile compiled from public source records

Public Record Profile Registrations: 3 510(k) filings: 0 Recalls: 1

Known Identifiers & Locations

FEI Numbers 1000132370, 3007014520, 3009265194
Owner Operator Numbers 9006473
Locations Covered ALPHARETTA, GA, US; Alpharetta, GA, US; Santo Domingo Este, DO

Registered Establishments (3)

Registration # Establishment Name Location Establishment Type(s) Action
1056553 REMINGTON MEDICAL, INC. ALPHARETTA, GA, US Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3007014520 Remington Medical, Inc. Alpharetta, GA, US Manufacture Medical Device View Details
3009265194 Remington Medical, S.A. Santo Domingo Este, DO Manufacture Medical Device for Another Party (Contract Manufacturer) View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (1)

Recall # Product Description Initiation Date Status Action
Z-0028-2013 Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument. The needles have an echogenic tip for accurate placement under ultrasound guidance and centimeter markings along the cannula to facilitate depth placement. Reason: Sterility of the product may be compromised. 2012-08-29 Terminated View Details

Profile Disclaimer

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