Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Class Implantable

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Verso Pump and Mattress
Wellell Inc.
Verso Pump and Mattress
In Commercial Distribution

  • 04713025005948 ()


  • Alternating-pressure chair cushion, reusable
Pro-care Optima Prone Pump and Mattress
Wellell Inc.
Pro-care Optima Prone Pump and Mattress
In Commercial Distribution

  • 04713025005610 ()


  • Alternating-pressure chair cushion, reusable
TC-FFL Interlayer Foils
INSPIRATION HEALTHCARE LIMITED
TC-FFL
In Commercial Distribution

  • 05060206921788 ()


  • External circulating-fluid core temperature regulation system pad, reusable
Repose Trolley Companion Cover
Frontier Therapeutics Inc
6990012
In Commercial Distribution

  • 05056279301022 ()


  • Air-filled bed mattress overlay
Repose Companion Cover
Frontier Therapeutics Inc
6990002
In Commercial Distribution

  • 05056279301008 ()


  • Waterproof bed mattress cover, reusable
Repose Trolley Mattress Cover
Frontier Therapeutics Inc
6980001
In Commercial Distribution

  • 05056279300988 ()


  • Waterproof bed mattress cover, reusable
Repose Contur Cover
Frontier Therapeutics Inc
6310000
In Commercial Distribution

  • 05056279300940 ()


  • Air-filled chair cushion
Repose Blue Cushion over EU 45cm
Frontier Therapeutics Inc
6211101
In Commercial Distribution

  • 05056279300889 ()


  • Waterproof bed mattress cover, reusable
Dermatherapy Quilted Underpad with WrapPel Barrier, Non-Woven Soaker, Size 34x36
STANDARD TEXTILE CO., INC.
59751100
Not in Commercial Distribution

  • 10634916827771 ()
  • 00634916827774 ()


  • Absorbent underpad, non-antimicrobial, reusable
Quilted Underpad, 80% Cotton/20% Poly Face Fabric, 95% Poly/5% Rayon Soaker/Vinyl Barrier, size 33x36, RFID chip in pouch
STANDARD TEXTILE CO., INC.
59748300
In Commercial Distribution

  • 10634916821021 ()
  • 00634916821024 ()


  • Absorbent underpad, non-antimicrobial, reusable
DermaTherapy Fitted Sheet, 50% Polyester / 50% Nylon, Encased Elastic Hem all Around with Blue Thread, 35x84x11
STANDARD TEXTILE CO., INC.
17810500
Not in Commercial Distribution

  • 10634916578710 ()
  • 00634916578713 ()


  • Absorbent underpad, non-antimicrobial, reusable
DermaTherapy Fitted Sheet, 50% Polyester / 50% Nylon, Encased Elastic Hem all Around, 37x79x10
STANDARD TEXTILE CO., INC.
17810100
In Commercial Distribution

  • 10634916508960 ()
  • 00634916508963 ()


  • Absorbent underpad, non-antimicrobial, reusable
Euro Tech Plus Quilted Underpad, 1 Ply laminated with PU Barrier
STANDARD TEXTILE CO., INC.
59750200
In Commercial Distribution

  • 00634916504705 ()
  • 10634916504702 ()
59750200

  • Absorbent underpad, non-antimicrobial, reusable
UNDERPAD DERMATHERAPY QLTD W/WRAPPEL BARRIER, 7.5 oz Non-Woven, Mock Safety Stitch Construction 42x50
STANDARD TEXTILE CO., INC.
59751900
Not in Commercial Distribution

  • 00634916391459 ()
  • 10634916391456 ()
59751900

  • Absorbent underpad, non-antimicrobial, reusable
UNDERPAD QUILTED KAUM W/TUCK-INS 33X36 RM (98-7998) USE: 59750101
STANDARD TEXTILE CO., INC.
597E0200
Not in Commercial Distribution

  • 00634916357875 ()
  • 10634916357875 ()
597E0200

  • Absorbent underpad, non-antimicrobial, reusable
UNDERPAD INTEGRITY PLUS KAUM 33X36 RM (98-8084) USE: 59782100
STANDARD TEXTILE CO., INC.
597C1800
In Commercial Distribution

  • 00634916348934 ()
  • 10634916348931 ()
597C1800

  • Absorbent underpad, non-antimicrobial, reusable
SHEET DERM BARI WHITE 48X80X11 ELASTIC ALL ARND PURPLE THRD
STANDARD TEXTILE CO., INC.
17810400
In Commercial Distribution

  • 10634916341932 ()
  • 00634916341935 ()
17810400

  • Absorbent underpad, non-antimicrobial, reusable
UNDERPAD DERMATHERAPY QLTD 34X36 WHITE W/WRAPPEL BARRIER SR16170
STANDARD TEXTILE CO., INC.
59750800
In Commercial Distribution

  • 00634916341928 ()
  • 10634916341925 ()
59750800

  • Absorbent underpad, non-antimicrobial, reusable
SHEET DERM ICU WHITE 36X78X16 W/ELASTIC ALL AROUND(SR 16027)
STANDARD TEXTILE CO., INC.
17810300
In Commercial Distribution

  • 10634916341918 ()
  • 00634916341911 ()
17810300

  • Absorbent underpad, non-antimicrobial, reusable
DermaTherapy Pillowcase, 50% Polyester / 50% Nylon, 4 1/2" Inner Flap, Size 20x30
STANDARD TEXTILE CO., INC.
17810000
In Commercial Distribution

  • 10634916341901 ()
  • 00634916341904 ()
17810000

  • Absorbent underpad, non-antimicrobial, reusable
SHEET DERMATHERAPY WHITE 66X99 HEMMED ALL SIDES (SR 15594)
STANDARD TEXTILE CO., INC.
17810200
In Commercial Distribution

  • 10634916341895 ()
  • 00634916341898 ()
17810200

  • Absorbent underpad, non-antimicrobial, reusable
UNDERPAD INTEGRITY 2PLY KAUM 33X36 RM (98-8397) USE: 59782000
STANDARD TEXTILE CO., INC.
597Y3500
In Commercial Distribution

  • 00634916336399 ()
  • 10634916336396 ()
597Y3500

  • Absorbent underpad, non-antimicrobial, reusable
UNDERPAD QUILTED IBEX PLAID KAUM 33X36 RM (98-7885) USE: 59710110
STANDARD TEXTILE CO., INC.
597Y1110
Not in Commercial Distribution

  • 00634916335200 ()
  • 10634916335207 ()
597Y1110

  • Absorbent underpad, non-antimicrobial, reusable
UNDERPAD QUILTED KAUM BLUE/GRN 33X36 RM (98 8385) USE: 59740200
STANDARD TEXTILE CO., INC.
597X6900
In Commercial Distribution

  • 00634916326147 ()
  • 10634916326144 ()
597X6900

  • Absorbent underpad, non-antimicrobial, reusable
UNDERPAD QUILTED IBEX KAUM 33X36 RM (98 8371) USE: 59710110
STANDARD TEXTILE CO., INC.
597X2710
Not in Commercial Distribution

  • 00634916322231 ()
  • 10634916322238 ()
597X2710

  • Absorbent underpad, non-antimicrobial, reusable
UNDERPAD QUILTED POLY BLUE/GRN 34X48 EURO TECH LAMINATED W/PU BARRIER
STANDARD TEXTILE CO., INC.
59740100
In Commercial Distribution

  • 00634916317879 ()
  • 10634916317876 ()
59740100

  • Absorbent underpad, non-antimicrobial, reusable
EXCEL PLUS COMPLY PAD KAUM 30X36 RM (98 8303) USE: 61064100
STANDARD TEXTILE CO., INC.
610V4700
Not in Commercial Distribution

  • 00634916302486 ()
  • 10634916302486 ()
610V4700

  • Absorbent underpad, non-antimicrobial, reusable
UNDERPAD DERMATHERAPY QUILTED 34X45 WHITE W/WRAPPEL BARR SR17716
STANDARD TEXTILE CO., INC.
59751800
In Commercial Distribution

  • 00634916297799 ()
  • 10634916297796 ()
59751800

  • Absorbent underpad, non-antimicrobial, reusable
UNDERPAD TWILL TAN KAUM 33X36 RM (98 7559) USE: 59750113
STANDARD TEXTILE CO., INC.
597U2613
Not in Commercial Distribution

  • 00634916283631 ()
  • 10634916283631 ()
597U2613

  • Absorbent underpad, non-antimicrobial, reusable
UNDERPAD INTEGRITY PLUS KAUM 33X36 RM (98 8271) USE: 59782100
STANDARD TEXTILE CO., INC.
597U0200
In Commercial Distribution

  • 00634916277906 ()
  • 10634916277903 ()
597U0200

  • Absorbent underpad, non-antimicrobial, reusable
UNDERPAD QUILTED IBEX POLY KAUM 33X36 RM (98 8276) USE: 59748100
STANDARD TEXTILE CO., INC.
597T5800
Not in Commercial Distribution

  • 00634916275131 ()
  • 10634916275138 ()
597T5800

  • Absorbent underpad, non-antimicrobial, reusable
UNDERPAD DERMATHERAPY QUILTED 38X50 WHITE W/WRAPPEL BARRIER
STANDARD TEXTILE CO., INC.
59750900
In Commercial Distribution

  • 00634916265613 ()
  • 10634916265610 ()
59750900

  • Absorbent underpad, non-antimicrobial, reusable
UNDERPAD QUILTED IBEX POLY KAUM 33X36 RM (98 8265) USE: 59748100
STANDARD TEXTILE CO., INC.
597T1900
In Commercial Distribution

  • 00634916263565 ()
  • 10634916263562 ()
597T1900

  • Absorbent underpad, non-antimicrobial, reusable
UNDERPAD QUILTED IBEX POLY KAUM 33X36 RM (98 8150) USE: 59748100
STANDARD TEXTILE CO., INC.
597R8200
Not in Commercial Distribution

  • 00634916260441 ()
  • 10634916260448 ()
597R8200

  • Absorbent underpad, non-antimicrobial, reusable
UNDERPAD TRUVAL KAUM 36X41 GREEN RM (98 8045) USE: 59785100
STANDARD TEXTILE CO., INC.
597Q6500
Not in Commercial Distribution

  • 00634916251371 ()
  • 10634916251378 ()
597Q6500

  • Absorbent underpad, non-antimicrobial, reusable
UNDERPAD QUILTED IBEX POLY KAUM 33X36 RM (98 8226) USE: 59748100
STANDARD TEXTILE CO., INC.
597Q2900
Not in Commercial Distribution

  • 00634916249347 ()
  • 10634916249347 ()
597Q2900

  • Absorbent underpad, non-antimicrobial, reusable
UNDERPAD TRUVAL KAUM 36X41 GREEN RM (98 7471) USE: 59785100
STANDARD TEXTILE CO., INC.
597Q0800
Not in Commercial Distribution

  • 00634916248739 ()
  • 10634916248739 ()
597Q0800

  • Absorbent underpad, non-antimicrobial, reusable
UNDERPAD QUILTED KAUM IBEX 33X36 RM (98 6656) USE: 59750110
STANDARD TEXTILE CO., INC.
597P1010
Not in Commercial Distribution

  • 00634916244083 ()
  • 10634916244083 ()
597P1010

  • Absorbent underpad, non-antimicrobial, reusable
UNDERPAD TRUVAL KAUM 33X36 GREEN RM (98 6672) USE: 59783100
STANDARD TEXTILE CO., INC.
597N3800
Not in Commercial Distribution

  • 00634916233711 ()
  • 10634916233711 ()
597N3800

  • Absorbent underpad, non-antimicrobial, reusable
UNDERPAD QUILTED IBEX POLY KAUM 33X36 RM (98 8173) USE: 59748100
STANDARD TEXTILE CO., INC.
597M6000
Not in Commercial Distribution

  • 00634916226966 ()
  • 10634916226966 ()
597M6000

  • Absorbent underpad, non-antimicrobial, reusable
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