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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On1 IOS Healing Cap 4.5 mm NP
Nobel Biocare AB
38735
In Commercial Distribution

  • 07332747113709 ()

  • Height: 4.500 Millimeter
38735

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 6 mm NP
Nobel Biocare AB
38734
In Commercial Distribution

  • 07332747113693 ()

  • Height: 6.000 Millimeter
38734

  • Dental implant suprastructure, temporary, preformed, single-use
NP IOS Model Implant Replica CC 3.0
Nobel Biocare AB
38188
Not in Commercial Distribution

  • 07332747175936 ()

  • Outer Diameter: 3.000 Millimeter
38188

  • Dental implant suprastructure, temporary, preformed, single-use
SFTWR MMT-6104 MM MBL CLIN IOS 1.0.0
MEDTRONIC MINIMED, INC.
MMT-6104
Not in Commercial Distribution

  • 00763000480677 ()


  • Self-care monitoring/reporting software
Lumify Diagnostic Ultrasound System iOS Release 5.1
Philips Ultrasound LLC
795161
In Commercial Distribution

  • 00884838124141 ()


  • General-purpose ultrasound imaging system
G5 Mobile IOS App Stand Alone Software
Dexcom, Inc.
SW10611
In Commercial Distribution

  • 00386270000002 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
SFTWR MMT-8400 1.1 CGM MODULE IOS US
MEDTRONIC MINIMED, INC.
MMT-8400
In Commercial Distribution

  • 00763000721350 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Aadva™ IOS 100: IOS cart, IOS Handpiece (via USB connection), CPU (onboard computer), G.U.I. touchscreen, holder inserts bags of 10, plug, IFUs (includes: Quick Start Guide & Owners manual).
Gc America Inc.
940502
In Commercial Distribution

  • J0229405021 ()
940502

  • Dental milling system, CAD/CAM, laboratory
DERMATHERAPY UNDERPAD; PAD 36IN-EA
JOERNS HEALTHCARE, LLC
DT-PAD-3436-EA
In Commercial Distribution

  • 20857268006947 ()
  • 00857268006943 ()


  • Antimicrobial bed linen set
DERMATHERAPY UNDERPAD; PAD 45IN-EA
JOERNS HEALTHCARE, LLC
DT-PAD-3445-EA
In Commercial Distribution

  • 20857268006930 ()
  • 00857268006936 ()


  • Antimicrobial bed linen set
DERMA THEREAPY UNDERPAD; PAD 50IN-EA
JOERNS HEALTHCARE, LLC
DT-PAD-3850-EA
In Commercial Distribution

  • 20857268006923 ()
  • 00857268006929 ()


  • Antimicrobial bed linen set
DermaTherapy MED Linen;FIT 42-48X80-EA
JOERNS HEALTHCARE, LLC
DT-MCM-4880P-EA
In Commercial Distribution

  • 20857268006916 ()
  • 00857268006912 ()


  • Antimicrobial bed linen set
DermaTherapy MED Linen;FIT 36X80 EA
JOERNS HEALTHCARE, LLC
DT-MCM-3680Y-EA
In Commercial Distribution

  • 20857268006909 ()
  • 00857268006905 ()


  • Antimicrobial bed linen set
DermaTherapy Med Linen;PillowCase-EA
JOERNS HEALTHCARE, LLC
DT-PILL-2030-EA
In Commercial Distribution

  • 00857268006899 ()
  • 20857268006893 ()


  • Antimicrobial bed linen set
Stretcher Sheet, White, SMS 108x51
ICP MEDICAL, LLC
1
In Commercial Distribution

  • 00688162000481 ()

  • Length: 96 Inch
  • Width: 37 Inch
ICP-9003GUR

  • Waterproof bed mattress cover, reusable
Stretcher Sheet, White, SMS 96x37
ICP MEDICAL, LLC
2
In Commercial Distribution

  • 10688162000464 ()
  • 00688162000467 ()
  • 20688162000461 ()

  • Length: 96 Inch
  • Width: 37 Inch
ICP-9001GUR

  • Waterproof bed mattress cover, reusable
EXCEL PLUS COMPLY QUILTED PAD KAUM 30X36 RM (98 6465) USE: 61064100
STANDARD TEXTILE CO., INC.
61064P41
Not in Commercial Distribution

  • 00634916014396 ()
  • 10634916014393 ()
61064P41

  • Absorbent underpad, non-antimicrobial, reusable
Silver Coverlet with Zipper
KREG MEDICAL INC.
ASM100118
In Commercial Distribution

  • 00850520008211 ()


  • Waterproof bed mattress cover, reusable
  • Antimicrobial bed mattress cover
Deep Purple Coverlet with Zipper
KREG MEDICAL INC.
ASM100117
In Commercial Distribution

  • 00850520008204 ()


  • Waterproof bed mattress cover, reusable
  • Antimicrobial bed mattress cover
5" Version
Trinity Guardion, Inc.
Universal Stretcher UNVST5-0000
In Commercial Distribution

  • 00850045714406 ()


  • Waterproof bed mattress cover, reusable
No Description
Trinity Guardion, Inc.
Giraffe Standard GIRSTD-0000
In Commercial Distribution

  • 00850045714369 ()
  • 00850045714376 ()
  • 00850045714383 ()
  • 00850045714390 ()


  • Waterproof bed mattress cover, reusable
No Description
Trinity Guardion, Inc.
Universal Pediatric 26191X-0000
In Commercial Distribution

  • 00850045714321 ()
  • 00850045714338 ()
  • 00850045714345 ()
  • 00850045714352 ()


  • Waterproof bed mattress cover, reusable
Replacement Mattress Cover for 10424 & 10428, 80" x 36" x 6", Blue
Dynarex Corporation
10487
In Commercial Distribution

  • 00616784048710 ()
  • 00616784048741 ()


  • Waterproof bed mattress cover, reusable
80" x 36" x 6"
Dynarex Corporation
10485
In Commercial Distribution

  • 00616784048512 ()


  • Bed mattress/cover set
Replacement Mattress Cover for 10420 & 10426, 80" x 36" x 6", Blue
Dynarex Corporation
10482
In Commercial Distribution

  • 00616784048215 ()
  • 00616784048246 ()


  • Waterproof bed mattress cover, reusable
Replacement Mattress Cover for 10422 & 10429, 80" x 36" x 6", Blue
Dynarex Corporation
10481
In Commercial Distribution

  • 00616784048116 ()
  • 00616784048147 ()


  • Waterproof bed mattress cover, reusable
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
Table Paper Crepe 14"x125ft. white
Dynarex Corporation
4485
In Commercial Distribution

  • 00616784448527 ()
  • 00616784448534 ()


  • Examination/treatment table paper
Headrest Table Paper Crepe 8"x125ft, white
Dynarex Corporation
4484
In Commercial Distribution

  • 00616784448428 ()
  • 00616784448435 ()


  • Examination/treatment table paper
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
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