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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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Dilapan-S - 08595231700260

Dilapan-S is a hygroscopic cervical dilator similar in shape to natural laminaria tents. It consists from the active part, made from the hydrophilic material (AQUACRYL 90), from the polypropylene handle, attached to the active part by the isocyanate adhesive, and from the polyamide signal string. Dilapan-S is capable of increasing in diameter as it absorbs moisture from the genital tract.
MEDICEM Technology s.r.o.
DS465
In Commercial Distribution

  • 08595231700345 ()
  • 08595231700260 ()
  • 08595231700338 ()
  • 08595231703131 ()
  • 08595231703148 ()

  • Outer Diameter: 4 Millimeter
  • Length: 65 Millimeter
4x65 mm

  • Hygroscopic cervical dilator

Laminaria - GYNX161051

No Description
GYNEX CORPORATION
16-105
In Commercial Distribution

  • GYNX161051 ()
  • GYNX16105 ()


  • Hygroscopic cervical dilator

Laminaria - GYNX161041

No Description
GYNEX CORPORATION
16-104
In Commercial Distribution

  • GYNX161041 ()
  • GYNX161040 ()


  • Hygroscopic cervical dilator

Laminaria - GYNX161031

No Description
GYNEX CORPORATION
16-103
In Commercial Distribution

  • GYNX161031 ()
  • GYNX161030 ()


  • Hygroscopic cervical dilator

Dilateria - 00888937003321

Kit contents: One dilateria; thick (5mm), 2 gauze sponge envelops and IFU
Coopersurgical, Inc.
MX230
Not in Commercial Distribution

  • 60888937003323 ()
  • 00888937003321 ()

  • Outer Diameter: 5 Millimeter


  • Hygroscopic cervical dilator

Dilateria - 00888937003314

Kit contents: One dilateria, medium (4mm); 2 gauze sponge envelopes and IFU
Coopersurgical, Inc.
MX220
Not in Commercial Distribution

  • 60888937003316 ()
  • 00888937003314 ()

  • Outer Diameter: 4 Millimeter


  • Hygroscopic cervical dilator

Dilateria - 00888937003307

Kit contents: One dilateria, thin (3mm), 2 gauze sponge envelopes and IFU
Coopersurgical, Inc.
MX210
Not in Commercial Distribution

  • 60888937003309 ()
  • 00888937003307 ()

  • Outer Diameter: 3 Millimeter


  • Hygroscopic cervical dilator

Dilateria - 00888937003338

Kit contents: One dilateria, extra thick (6mm), 2 gauze sponge envelopes and IFU
Coopersurgical, Inc.
MX240
Not in Commercial Distribution

  • 60888937003330 ()
  • 00888937003338 ()

  • Outer Diameter: 6 Millimeter


  • Hygroscopic cervical dilator

BMT Medizintechnik GmbH - 04251725219345

FORCEPS MOLARS #24
BMT Medizintechnik GmbH
AM-24
In Commercial Distribution

  • 04251725219345 ()
AM-24

  • Tooth extraction forceps

24" NAFION LINE - 00612649191089

NAFION LINE 24"
King Systems Corporation
7084
In Commercial Distribution

  • 00612649191089 ()
  • 00612649112251 ()
7084

  • Gas-sampling/monitoring respiratory tubing, single-use

HIgH-Flo™, RMS Precision Flow Rate TubingTM - 00659443000698

24" Tubing Extender
REPRO MED SYSTEMS, INC.
FEXT
In Commercial Distribution

  • 10659443000695 ()
  • 00659443000698 ()

  • Length: 24 Inch
FEXT

  • Mechanical infusion pump administration set

HU-FRIEDY - 10889950007218

#24 Cement Spatula
HU-FRIEDY MFG. CO., LLC
CS24
In Commercial Distribution

  • 10889950007218 ()
CS24

  • Dental spatula, reusable

OneBite Evolution - 00850031761476

OneBite Arches (24)
Precision Dental Products LLC
OBA024
In Commercial Distribution

  • 00850031761476 ()
OBA024

  • Bite registration rim

N/A - 04961333243969

24" STANDARD MONITOR
PENTAX OF AMERICA, INC.
MONITOR ST
In Commercial Distribution

  • 04961333243969 ()

  • Length: 24.0 Inch


  • Endoscopic video image display unit

N/A - 00858308006527

Ortho Deck 24
Ergonomic Products, Inc.
D1F2
In Commercial Distribution

  • 00858308006527 ()
D1F2

  • Dental delivery system

Prefense - 00851725007030

Prefense 24" display
Nihon Kohden Digital Health Solutions, LLC
EDNS-WS24
In Commercial Distribution

  • 00851725007030 ()
EDNS-WS24

  • Centralized patient monitor

Nisus NPWT Accessory - 00851675007081

24" Tubing Extension
CORK MEDICAL, LLC
CSP-100-ES-EXT
In Commercial Distribution

  • 00851675007081 ()


  • Negative-pressure wound therapy system dressing set

BMT Medizintechnik GmbH - 04251725201807

RASPATORY, #24 G
BMT Medizintechnik GmbH
718-24G
In Commercial Distribution

  • 04251725201807 ()
718-24G

  • Periosteal elevator, reusable

WorkMate Claris™ - 05415067013125

Cart 24 Inch
ST. JUDE MEDICAL, INC.
H701312
In Commercial Distribution

  • 05415067013125 ()
H701312

  • Cardiac catheterization monitoring system

Bioseal Inc. - 00630094969527

Silicone Tubing 24"
BIOSEAL
19695/25
In Commercial Distribution

  • 10630094969524 ()
  • 00630094969527 ()


  • Suction/irrigation tubing, single-use

Bioseal Inc. - 00630094963242

Latex Tubing 24"
BIOSEAL
19632D/25
In Commercial Distribution

  • 10630094963249 ()
  • 00630094963242 ()


  • Suction/irrigation tubing, single-use

Bioseal Inc. - 00630094785516

Silicone Tubing 24"
BIOSEAL
19785NS/20
In Commercial Distribution

  • 10630094785513 ()
  • 00630094785516 ()


  • Suction/irrigation tubing, single-use

Bioseal Inc. - 00630094197746

Silicone Tubing 24"
BIOSEAL
19774/20
In Commercial Distribution

  • 10630094197743 ()
  • 00630094197746 ()


  • Suction/irrigation tubing, single-use

Bioseal Inc. - 00630094197678

Turner Tube 24"
BIOSEAL
19767/20
In Commercial Distribution

  • 10630094197675 ()
  • 00630094197678 ()


  • Suction/irrigation tubing, single-use

Bioseal Inc. - 00630094196909

Silicone Tubing 24"
BIOSEAL
19690/25
In Commercial Distribution

  • 10630094196906 ()
  • 00630094196909 ()


  • Suction/irrigation tubing, single-use

Bioseal Inc. - 00630094196213

Suction Tubing 24"
BIOSEAL
19621/20
In Commercial Distribution

  • 10630094196210 ()
  • 00630094196213 ()


  • Suction/irrigation tubing, single-use

HU-FRIEDY - 10889950123734

SEXL 24 Spatula
HU-FRIEDY MFG. CO., LLC
3U0010
In Commercial Distribution

  • 10889950123734 ()
3U0010

  • Dental spatula, reusable

EASYLINER - 00713980002017

Easyliner - Size 24
Alps South, LLC
ELPX-24
In Commercial Distribution

  • 00713980002017 ()


  • External limb prosthesis socket liner

Venti-Scan - 00718175001929

Venti-Scan 24" Tubing
BIODEX MEDICAL SYSTEMS, INC.
177-092
In Commercial Distribution

  • 00718175001929 ()
  • 30718175001951 ()
  • 20718175001947 ()
  • 10718175001933 ()
177-092

  • Radioaerosol administration set

Med-Mizer, Inc. - 00852195007179

FLEXTILT 24 Chair
MED-MIZER, INC.
FLEXTILT 24
In Commercial Distribution

  • 00852195007179 ()


  • Assistive ergonomic chair, manually-adjusted

Henry Schein - 00304040045596

Spatula Cement 24
HENRY SCHEIN, INC.
1005231
In Commercial Distribution

  • 00304040045596 ()
1005231

  • Dental spatula, reusable

HOPKINS - 04048551290637

Compact-Cysto-Urethroscope, 24 Fr.
Karl Storz GmbH & Co. KG
26035FA
In Commercial Distribution

  • 04048551290637 ()


  • Rigid optical cystourethroscope

NORDENT MANUFACTURING INC - 00840018634398

MODIFIED SPATULA 24
NORDENT MANUFACTURING INC
SP24M
In Commercial Distribution

  • 00840018634398 ()


  • Dental spatula, reusable

NORDENT MANUFACTURING INC - 00840018634381

CEMENT SPAT #24
NORDENT MANUFACTURING INC
SP24
In Commercial Distribution

  • 00840018634381 ()


  • Dental spatula, reusable

TOX II_10 24 - B800TOXII10240

TOX II_10 24
UTAK LABORATORIES, INC.
TOX II_10 24
In Commercial Distribution

  • B800TOXII10245 ()
  • B800TOXII10240 ()

  • Total Volume: 1 Milliliter
TOX II_10 24

  • Multiple drugs of abuse IVD, control

TOX II_09 24 - B800TOXII09240

TOX II_09 24
UTAK LABORATORIES, INC.
TOX II_09 24
In Commercial Distribution

  • B800TOXII09245 ()
  • B800TOXII09240 ()

  • Total Volume: 1 Milliliter
TOX II_09 24

  • Multiple drugs of abuse IVD, control

TOX II_08 24 - B800TOXII08240

TOX II_08 24
UTAK LABORATORIES, INC.
TOX II_08 24
In Commercial Distribution

  • B800TOXII08245 ()
  • B800TOXII08240 ()

  • Total Volume: 1 Milliliter
TOX II_08 24

  • Multiple drugs of abuse IVD, control

TOX II_07 24 - B800TOXII07240

TOX II_07 24
UTAK LABORATORIES, INC.
TOX II_07 24
In Commercial Distribution

  • B800TOXII07240 ()

  • Total Volume: 1 Milliliter
TOX II_07 24

  • Multiple drugs of abuse IVD, control

TOX II_06 24 - B800TOXII06240

TOX II_06 24
UTAK LABORATORIES, INC.
TOX II_06 24
In Commercial Distribution

  • B800TOXII06245 ()
  • B800TOXII06240 ()

  • Total Volume: 1 Milliliter
TOX II_06 24

  • Multiple drugs of abuse IVD, control

TOX I_05 24 - B800TOXI05240

TOX I_05 24
UTAK LABORATORIES, INC.
TOX I_05 24
In Commercial Distribution

  • B800TOXI05245 ()
  • B800TOXI05240 ()

  • Total Volume: 1 Milliliter
TOX I_05 24

  • Multiple-type clinical chemistry analyte profile IVD, control

TOX I_04 24 - B800TOXI04240

TOX I_04 24
UTAK LABORATORIES, INC.
TOX I_04 24
In Commercial Distribution

  • B800TOXI04245 ()
  • B800TOXI04240 ()

  • Total Volume: 1 Milliliter
TOX I_04 24

  • Multiple-type clinical chemistry analyte profile IVD, control

TOX I_03 24 - B800TOXI03240

TOX I_03 24
UTAK LABORATORIES, INC.
TOX I_03 24
In Commercial Distribution

  • B800TOXI03245 ()
  • B800TOXI03240 ()

  • Total Volume: 1 Milliliter
TOX I_03 24

  • Multiple-type clinical chemistry analyte profile IVD, control

TOX I_02 24 - B800TOXI02240

TOX I_02 24
UTAK LABORATORIES, INC.
TOX I_02 24
In Commercial Distribution

  • B800TOXI02245 ()
  • B800TOXI02240 ()

  • Total Volume: 1 Milliliter
TOX I_02 24

  • Multiple-type clinical chemistry analyte profile IVD, control

TOX I_01 24 - B800TOXI01240

TOX I_01 24
UTAK LABORATORIES, INC.
TOX I_01 24
In Commercial Distribution

  • B800TOXI01245 ()
  • B800TOXI01240 ()

  • Total Volume: 1 Milliliter
TOX I_01 24

  • Multiple-type clinical chemistry analyte profile IVD, control

ETOH II_10 24 - B800ETOHII10240

ETOH II_10 24
UTAK LABORATORIES, INC.
ETOH II_10 24
In Commercial Distribution

  • B800ETOHII10245 ()
  • B800ETOHII10240 ()

  • Total Volume: 1.25 Milliliter
ETOH II_10 24

  • Multiple drugs of abuse IVD, control

ETOH II_09 24 - B800ETOHII09240

ETOH II_09 24
UTAK LABORATORIES, INC.
ETOH II_09 24
In Commercial Distribution

  • B800ETOHII09245 ()
  • B800ETOHII09240 ()

  • Total Volume: 1.25 Milliliter
ETOH II_09 24

  • Multiple drugs of abuse IVD, control

ETOH II_08 24 - B800ETOHII08240

ETOH II_08 24
UTAK LABORATORIES, INC.
ETOH II_08 24
In Commercial Distribution

  • B800ETOHII08244 ()
  • B800ETOHII08240 ()

  • Total Volume: 1.25 Milliliter
ETOH II_08 24

  • Multiple drugs of abuse IVD, control

ETOH II_07 24 - B800ETOHII07240

ETOH II_07 24
UTAK LABORATORIES, INC.
ETOH II_07 24
In Commercial Distribution

  • B800ETOHII07245 ()
  • B800ETOHII07240 ()

  • Total Volume: 1.25 Milliliter
ETOH II_07 24

  • Multiple drugs of abuse IVD, control

ETOH II_06 24 - B800ETOHII06240

ETOH II_06 24
UTAK LABORATORIES, INC.
ETOH II_06 24
In Commercial Distribution

  • B800ETOHII06245 ()
  • B800ETOHII06240 ()

  • Total Volume: 1.25 Milliliter
ETOH II_06 24

  • Multiple drugs of abuse IVD, control

ETOH I_05 24 - B800ETOHI05240

ETOH I_05 24
UTAK LABORATORIES, INC.
ETOH I_05 24
In Commercial Distribution

  • B800ETOHI05245 ()
  • B800ETOHI05240 ()

  • Total Volume: 1.25 Milliliter
ETOH I_05 24

  • Multiple-type clinical chemistry analyte profile IVD, control
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