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 Size Type Device Class Implantable

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Detection of Rheumatoid Factor
ARLINGTON SCIENTIFIC, INC.
NC-700025DC-E
In Commercial Distribution

  • 00816057020478 ()

  • 25 Tests
NC-700025DC-E

  • Rheumatoid factor IVD, kit, agglutination
Detection of Rheumatoid Factor
ARLINGTON SCIENTIFIC, INC.
NC-700025DC
In Commercial Distribution

  • 00816057020461 ()

  • 25 Tests
NC-700025DC

  • Rheumatoid factor IVD, kit, agglutination
Detection of C-Reactive Protein, Export
ARLINGTON SCIENTIFIC, INC.
NC-500025E
In Commercial Distribution

  • 00816057020348 ()

  • 25 Tst
NC-500025E

  • C-reactive protein (CRP) IVD, kit, precipitation/immunodiffusion
Detection of C-Reactive Protein
ARLINGTON SCIENTIFIC, INC.
NC-500025
In Commercial Distribution

  • 00816057020331 ()

  • 25 Test
NC-500025

  • C-reactive protein (CRP) IVD, kit, precipitation/immunodiffusion
Detection of heterophil antibodies associated with infectious mononucleosis, Export
ARLINGTON SCIENTIFIC, INC.
NC-450025E
In Commercial Distribution

  • 00816057020270 ()

  • 25 Test
NC-450025E

  • Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination
Detection of heterophil antibodies associated with infectious mononucleosis
ARLINGTON SCIENTIFIC, INC.
NC-450025
In Commercial Distribution

  • 00816057020263 ()

  • 25 Test
NC-450025

  • Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination
Detection of Anti-DNP, associated with Systemic Lupus Erythematosus, Export
ARLINGTON SCIENTIFIC, INC.
NC-350025E
In Commercial Distribution

  • 00816057020201 ()

  • 25 Test
NC-350025E

  • Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, reagent
Detection of Anti-DNP, associated with Systemic Lupus Erythematosus
ARLINGTON SCIENTIFIC, INC.
NC-350025
In Commercial Distribution

  • 00816057020195 ()

  • 25 Test
NC-350025

  • Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, reagent
Detection of Anti-Strptolysin-O, Export
ARLINGTON SCIENTIFIC, INC.
NC-300025E
In Commercial Distribution

  • 00816057020133 ()

  • 25 Test
NC-300025E

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, reagent
Detection of Anti-Streptolysin O
ARLINGTON SCIENTIFIC, INC.
NC-300025
In Commercial Distribution

  • 00816057020126 ()

  • 25 Test
NC-300025

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, reagent
Detection of coagulase associated with Staph. aureus, Export
ARLINGTON SCIENTIFIC, INC.
NC-280-2-25CE
In Commercial Distribution

  • 00816057020072 ()

  • 25 Test
NC-280-2-25CE

  • Staphylococcus aureus culture isolate antigen IVD, kit, agglutination
Detection of coagulase associated with Staph aureus
ARLINGTON SCIENTIFIC, INC.
NC-280-2-25C
In Commercial Distribution

  • 00816057020065 ()

  • 25 Test
NC-280-2-25C

  • Staphylococcus aureus culture isolate antigen IVD, kit, agglutination
Detection of the presence of Hgb-S for Export
ARLINGTON SCIENTIFIC, INC.
NC-200025E
In Commercial Distribution

  • 00816057020010 ()

  • 25 Test
NC-200025E

  • Haemoglobin S (HbS) IVD, reagent
Detection of presence of Hgb-S
ARLINGTON SCIENTIFIC, INC.
NC-200025
In Commercial Distribution

  • 00816057020003 ()

  • 25 Test
NC-200025

  • Haemoglobin S (HbS) IVD, reagent
AN1004.00 EOGas 4 Refill Kit, 25 EO 17.6g cartridges, 25 AN1087 Dosimeters, 25 Humidichips, 26 EOGas 4 sterilization bags
ANDERSEN STERILIZERS INC.
AN1004.00
In Commercial Distribution

  • 05060485030164 ()
AN1004.00

  • Ethylene oxide sterilizer
Fabric Adhesive Knuckle Bandages (25) and Fabric Adhesive Fingertip Bandages (25) /Box
Acme United Corporation
G140
In Commercial Distribution

  • 00092265071406 ()
G140

  • Skin-cover adhesive strip, non-antimicrobial
Status iFOBT Mailers with Collection Tubes Kit (25 Mailers and 25 Tubes)
PRINCETON BIOMEDITECH CORPORATION
BSP-300-TM-01
In Commercial Distribution

  • 10743816001454 ()
BSP-300-TM-01

  • Faecal occult blood IVD, reagent
Steam Test Pack PCD Kit (25 test packs and 25 control BIs)
TERRAGENE S.A.
(K)PCD224-C
In Commercial Distribution

  • 07798164679769 ()


  • Biological sterilization indicator
Steam Test Pack PCD Kit (25 test packs and 25 control BIs)
TERRAGENE S.A.
KPCD224-2
In Commercial Distribution

  • 07798164679752 ()


  • Biological sterilization indicator
Steam Test Pack PCD Kit (25 test packs and 25 control BIs)
TERRAGENE S.A.
WTL198-0077
In Commercial Distribution

  • 07798164677390 ()


  • Biological sterilization indicator
Steam Test Pack PCD Kit (25 test packs and 25 control BIs)
TERRAGENE S.A.
WTL198-0075
In Commercial Distribution

  • 07798164677376 ()


  • Biological sterilization indicator
Steam Test Pack PCD Kit (25 test packs and 25 control BIs)
TERRAGENE S.A.
(K)PCD222-C
In Commercial Distribution

  • 07798164676027 ()


  • Biological sterilization indicator
Steam Test Pack PCD Kit (25 test packs and 25 control BIs)
TERRAGENE S.A.
KPCD220-C
In Commercial Distribution

  • 07798164675969 ()


  • Biological sterilization indicator
Steam Test Pack PCD Kit (25 test packs and 25 control BIs)
TERRAGENE S.A.
KPCD222-2
In Commercial Distribution

  • 07798164675624 ()


  • Biological sterilization indicator
Steam Test Pack PCD Kit (25 test packs and 25 control BIs)
TERRAGENE S.A.
KPCD220-2
In Commercial Distribution

  • 07798164675556 ()


  • Biological sterilization indicator
TQMPL Smart-Taper Heat Treated Endodontic Rotary Files - F2 - 08 - #25 - 25 mm
TOP QUALITY MANUFACTURING, INC.
12609148
In Commercial Distribution

  • TQ26126091480 ()
  • TQ26126091481 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
Filter, 1” (25 mm), 3/8” (9.5 mm), 1” (25 mm) Ports
Conmed Corporation
PX5-135
In Commercial Distribution

  • 10653405988007 ()
PX5-135

  • Surgical plume evacuation system filter
Polishers Shine - Cup sterile roll 25 Polishers Shine - Cup sterile roll 25
US ENDODONTICS, LLC
SCSR25
In Commercial Distribution

  • 10818365024435 ()
  • 00818365024438 ()
SCSR25

  • Carbide dental bur, single-use
Polishers Reveal - Point sterile roll 25 Polishers Reveal - Point sterile roll 25
US ENDODONTICS, LLC
RPSR25
In Commercial Distribution

  • 10818365023872 ()
  • 00818365023875 ()
RPSR25

  • Carbide dental bur, single-use
Polishers Shine - Point sterile roll 25 Polishers Shine - Point sterile roll 25
US ENDODONTICS, LLC
SPSR25
In Commercial Distribution

  • 10818365024060 ()
  • 00818365024063 ()
SPSR25

  • Carbide dental bur, single-use
Polishers Reveal - Cup sterile roll 25 Polishers Reveal - Cup sterile roll 25
US ENDODONTICS, LLC
RCSR25
In Commercial Distribution

  • 10818365023964 ()
  • 00818365023967 ()
RCSR25

  • Carbide dental bur, single-use
V. Mueller GRANDON I/A CANNULA GENTLE CURVE 25 GAUGE 25 GAUGE
CAREFUSION 2200, INC
OP0904-153
Not in Commercial Distribution

  • 10885403090936 ()
OP0904-153

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Filter, 1” (25 mm), 3/8” (9.5 mm), 1” (25 mm) Ports
Conmed Corporation
PX5-1354
In Commercial Distribution

  • 30653405988018 ()
PX5-1354

  • Surgical plume evacuation system filter
WagoTrix Matrix Intro Kit, includes:3.5mm Anatomical Matrix Refill - Qty 25, 4.5mm Anatomical Matrix Refill - Qty 25, 5.5mm Anatomical Matrix Refill - Qty 25, 6.5mm Anatomical Matrix Refill - Qty 25
GoldenDent
WGMIK
In Commercial Distribution

  • 00850028211403 ()
WGMIK

  • Dental matrix band kit
PARKER Wound Retractor, 7", (180 mm), double ended, 27 x 25 mm, 31 x 25 mm, 27 x 25 mm, 31 x 25 mm, non-sterile, reusable, Set of 2
Aesculap AG
BT026R
In Commercial Distribution

  • 04038653411566 ()
BT026R

  • Hand-held surgical retractor, reusable
25 Fabric XL Fingertip Bandages Latex Free Heavy Weight Wound Protection 25/box
REDICARE LLC
Fingertip XL Fabric Bandage
In Commercial Distribution

  • B70901030132 ()
  • B70901030131 ()
  • B70901030130 ()
0103013

  • Adhesive bandage
25 sets of Echo-Screen II Ear Couplers and 25 sets of Snap Electrodes.
NATUS MEDICAL INCORPORATED
Echo-PAK
In Commercial Distribution

  • 00382830051231 ()
  • 00382830053266 ()
1630-25-US

  • Ear simulator, acoustic coupler
  • Analytical scalp electrode, single-use
SofScale™ Calculus Scaling Gel, 25 Syringes (2mL) and 25 Disposable Applications Tips.
Dentsply Professional
A900300
In Commercial Distribution

  • D003A9003002 ()
  • D003A9003001 ()

  • Total Volume: 2 Milliliter


  • Dental scaling solution
Dural Repair Collagen Matrix 25 x 75 25 x 75mm (1 x 3in)
COLLAGEN MATRIX, INC.
KBI-DU 01 03-S
In Commercial Distribution

  • 00813954023786 ()

  • Width: 25 Millimeter
  • Length: 75 Millimeter


  • Dura mater biomatrix implant
HyFlex™ EDM Shaping Set Medium 20/0.05; 10/0.05; 25/~ 25 mm
Coltène/Whaledent GmbH + Co. KG
60022289
Not in Commercial Distribution

  • E165600222890 ()
60022289

  • Rotary/reciprocating endodontic file/rasp, reusable
HyFlex™ EDM Shaping Set Simple 25/0.12; 10/0.05; 25/~ 21 mm
Coltène/Whaledent GmbH + Co. KG
60022279
Not in Commercial Distribution

  • E165600222790 ()
60022279

  • Rotary/reciprocating endodontic file/rasp, reusable
SPINAL TRAY 22/25 WHITACRE
MEDLINE INDUSTRIES, INC.
DYNJRA1727
In Commercial Distribution

  • 10193489487954 ()
DYNJRA1727

  • General surgical procedure kit, medicated
Torque Indicating Wrench Size 25
K2M, INC.
101-90317
In Commercial Distribution

  • 10888857011267 ()
101-90317

  • Orthopaedic implant/instrument assembling device
Hexalobular Screw Remover Size 25
K2M, INC.
101-90305
In Commercial Distribution

  • 10888857011168 ()
101-90305

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Provisional Screwdriver (Long) Size 25
K2M, INC.
101-90290
In Commercial Distribution

  • 10888857011045 ()
101-90290

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Provisional Screwdriver (Short) Size 25
K2M, INC.
101-90288
In Commercial Distribution

  • 10888857011021 ()
101-90288

  • Orthopaedic implant driver
Torque Limiting Shaft Size 25
K2M, INC.
101-90101
In Commercial Distribution

  • 10888857010048 ()
101-90101

  • Surgical screwdriver, reusable
BULK LENS HOLDER 25/CS
MEDLINE INDUSTRIES, INC.
LENSHOLDB20
In Commercial Distribution

  • 40193489535816 ()
  • 10193489535815 ()
LENSHOLDB20

  • General surgical procedure kit, non-medicated, single-use
Universal Awl Size 25 mm
K2M, INC.
2008-90026
In Commercial Distribution

  • 10888857025516 ()
2008-90026

  • Bone awl, reusable
DISTRACTOR EX0314026 25 DEG 18X36
MEDTRONIC SOFAMOR DANEK, INC.
EX0314026
In Commercial Distribution

  • 00643169479746 ()


  • Orthopaedic surgical distractor, internal
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