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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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Bimanual I/A Systems - 25056030401798

23g Twin Pack Irr/Asp
STERIMEDIX LIMITED
M5536-02/5
In Commercial Distribution

  • 15056030401791 ()
  • 25056030401798 ()
M5536

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Bimanual I/A Systems - 25056030401743

21g TW x 16m Bimanual
STERIMEDIX LIMITED
M5531-02/5
In Commercial Distribution

  • 15056030401746 ()
  • 25056030401743 ()
M5531

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Bimanual Cannulae and Hand Pieces - 25056030401712

21g x 5/8" Bimanual Irr
STERIMEDIX LIMITED
M5521-02/5
In Commercial Distribution

  • 15056030401715 ()
  • 25056030401712 ()
M5521

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Bimanual Cannulae and Hand Pieces - 25056030401682

23g x 5/8" Bimanual Asp
STERIMEDIX LIMITED
M5518-02/5
In Commercial Distribution

  • 35056030401689 ()
  • 25056030401682 ()
M5518

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Bimanual Cannulae and Hand Pieces - 25056030401651

23g x 5/8" Bimanual Irr
STERIMEDIX LIMITED
M5513-02/5
In Commercial Distribution

  • 45056030401655 ()
  • 25056030401651 ()
M5513

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Bimanual Cannulae and Hand Pieces - 25056030401613

21g x 5/8" Bimanual Irr
STERIMEDIX LIMITED
M5505-02/5
In Commercial Distribution

  • 15056030401616 ()
  • 25056030401613 ()
M5505

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

NeuroSmart Autoclavable Drive Headstage - 07290114060967

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Rev. 5
In Commercial Distribution

  • 07290114060967 ()
700-006008-00

  • Depth electrode

Prismaflex - 07332414105266

The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy.
GAMBRO AB
5.XX
Not in Commercial Distribution

  • 07332414105266 ()
113081

  • Haemodialysis system, institutional

MocareHealth - 36971384153840

Sterile Polyisoprene Powder-Free Surgical Gloves - Natural
Motex Healthcare(Anhui)Co.,Ltd.
7621S/5
In Commercial Distribution

  • 36971384153840 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

MocareHealth - 36971384153741

Sterile Polyisoprene Powder-Free Surgical Gloves - Blue
Motex Healthcare(Anhui)Co.,Ltd.
7529F/5
In Commercial Distribution

  • 36971384153741 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

MocareHealth - 36971384153444

Sterile Nitrile Accelerator-Free and Sulfur-Free Powder-Free Surgical gloves - Green
Motex Healthcare(Anhui)Co.,Ltd.
7721F/5
In Commercial Distribution

  • 36971384153444 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

MocareHealth - 36971384153345

Sterile Latex Powder-Free Surgical gloves - Brown
Motex Healthcare(Anhui)Co.,Ltd.
2921S/5
In Commercial Distribution

  • 36971384153345 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

MocareHealth - 36971384153246

Sterile Latex Powder-Free Surgical gloves - Brown
Motex Healthcare(Anhui)Co.,Ltd.
2829F/5
In Commercial Distribution

  • 36971384153246 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

MocareHealth - 36971384153147

Sterile Latex Powder-Free Surgical gloves - Brown
Motex Healthcare(Anhui)Co.,Ltd.
2821S/5
In Commercial Distribution

  • 36971384153147 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

MocareHealth - 36971384153048

Sterile Latex Powder-Free Surgical gloves - Natural
Motex Healthcare(Anhui)Co.,Ltd.
2729S/5
In Commercial Distribution

  • 36971384153048 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

MocareHealth - 36971384152942

Sterile Latex Powder-Free Surgical gloves
Motex Healthcare(Anhui)Co.,Ltd.
2729F/5
In Commercial Distribution

  • 36971384152942 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

MocareHealth - 36971384153949

Sterile Polyisoprene Powder-Free Surgical Gloves - Natural
Motex Healthcare(Anhui)Co.,Ltd.
7629S/5
In Commercial Distribution

  • 36971384153949 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

MocareHealth - 36971384153642

Sterile Polyisoprene Powder-Free Surgical Gloves - Blue
Motex Healthcare(Anhui)Co.,Ltd.
7521F/5
In Commercial Distribution

  • 36971384153642 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

MocareHealth - 36971384153543

Sterile Nitrile Accelerator-Free and Sulfur-Free Powder-Free Surgical gloves - Green
Motex Healthcare(Anhui)Co.,Ltd.
7729F/5
In Commercial Distribution

  • 36971384153543 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

MocareHealth - 36971384152843

Sterile Latex Powder-Free Surgical gloves
Motex Healthcare(Anhui)Co.,Ltd.
2721S/5
In Commercial Distribution

  • 36971384152843 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

MIXPAC Protective Sleeve - 07350069421777

MIXPAC™ Protective Sleeves provide convenient and effective barrier protection of multi-use application systems to protect the dentist, staff and patient against cross-contamination and infectious disease during clinical use.
Minitube AB
5 ml
In Commercial Distribution

  • 07350069420770 ()
  • 07350069421777 ()
PRS 701-03

  • Medical equipment/instrument drape, single-use

FifthPulse - 00810084936887

Instant Cold Pack
Jeg & Sons Inc.
5 Pack
In Commercial Distribution

  • 00810084938355 ()
  • 00810084936887 ()
FMN100525

  • Hot/cold therapy pack, single-use

Nic Tone, MDC Dental - 07506338319324

NIC TONE Orthodontic Acrylic #5 90 g
MDC DENTAL
Orthodontic #5
In Commercial Distribution

  • 07506338319324 ()


  • Dental acrylic resin

Nic Tone, MDC Dental - 07506338319317

NIC TONE Orthodontic Acrylic #5 35 g
MDC DENTAL
Orthodontic #5
In Commercial Distribution

  • 07506338319317 ()


  • Dental acrylic resin

QUARZ, MDC Dental - 07506338318969

NIC TONE QUARZ Rapid Acrylic #5 35 g
MDC DENTAL
Rapid #5
In Commercial Distribution

  • 07506338318969 ()


  • Dental acrylic resin

ALGO Newborn Hearing Screener - 00382830043939

The ALGO 5 Newborn Hearing Screener is a mobile, cart-based, noninvasive instrument used to screen infants for hearing loss.
NATUS MEDICAL INCORPORATED
ALGO 5
In Commercial Distribution

  • 00382830043939 ()

  • Depth: 19.5 Inch
  • Width: 20 Inch
  • Height: 61.5 Inch
  • Weight: 140 Pound
004691

  • Evoked-potential audiometer

Coaxial Cannulae and Hand Pieces - 35056030401924

16/21g I/A Handpiece 90°
STERIMEDIX LIMITED
M5584-02/5
In Commercial Distribution

  • 25056030401927 ()
  • 35056030401924 ()
M5584

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Coaxial Cannulae and Hand Pieces - 35056030401900

16/21g I/A Handpiece 45°
STERIMEDIX LIMITED
M5582-02/5
In Commercial Distribution

  • 25056030401903 ()
  • 35056030401900 ()
M5582

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Bimanual Cannulae and Hand Pieces - 35056030401665

21g x 5/8" Bimanual Irr
STERIMEDIX LIMITED
M5514-02/5
In Commercial Distribution

  • 25056030401668 ()
  • 35056030401665 ()
M5514

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

JOHN BUNN - M3681398151

Jackson Trachea Tube Short Length
GF HEALTH PRODUCTS, INC.
1398-1#5
In Commercial Distribution

  • M3681398151 ()


  • Oesophageal-obturating/tracheal airway, reusable

JOHN BUNN - M3681395151

Jackson Trachea Tube Short Length
GF HEALTH PRODUCTS, INC.
1395-1#5
In Commercial Distribution

  • M3681395151 ()


  • Oesophageal-obturating/tracheal airway, reusable

DG Health Tampons - 00748364103028

plus cardboard applicator tampons
DOLGENCORP, LLC
DG32006F/5
In Commercial Distribution

  • 10748364103025 ()
  • 00748364103028 ()
  • 00074836410302 ()


  • Menstrual tampon, unscented

DG Health Tampons - 00748364103011

super cardboard applicator tampons
DOLGENCORP, LLC
DG22006F/5
In Commercial Distribution

  • 10748364103018 ()
  • 00748364103011 ()
  • 00074836410302 ()


  • Menstrual tampon, unscented

SonoBook Series Diagnostic Ultrasound Systems - 06945121414159

No Description
CHISON Medical Technologies Co., Ltd.
SonoBook 5
In Commercial Distribution

  • 06945121414166 ()
  • 06945121414159 ()
  • 06945121414173 ()


  • General-purpose ultrasound imaging system

CBit Series Digital Color Doppler Ultrasound System - 06945121413220

No Description
CHISON Medical Technologies Co., Ltd.
CBit 5
In Commercial Distribution

  • 06945121413220 ()


  • General-purpose ultrasound imaging system

ECO Series Diagnostic Ultrasound Systems - 06945121407342

No Description
CHISON Medical Technologies Co., Ltd.
ECO 5
In Commercial Distribution

  • 06945121408158 ()
  • 06945121407342 ()
  • 06945121408141 ()
  • 06945121408134 ()
  • 06945121408127 ()
  • 06945121408110 ()
  • 06945121408103 ()
  • 06945121408097 ()
  • 06945121408080 ()


  • Foetal Doppler system probe

QBit Series Diagnostic Ultrasound System - 06945121403221

No Description
CHISON Medical Technologies Co., Ltd.
QBit 5
In Commercial Distribution

  • 06945121403221 ()
  • 06945121404655 ()
  • 06945121404648 ()
  • 06945121404631 ()
  • 06945121404501 ()
  • 06945121404495 ()
  • 06945121404488 ()
  • 06945121404471 ()
  • 06945121404464 ()
  • 06945121404457 ()
  • 06945121404440 ()
  • 06945121404433 ()
  • 06945121404426 ()
  • 06945121404419 ()
  • 06945121404402 ()
  • 06945121404396 ()
  • 06945121404518 ()
  • 06945121404525 ()
  • 06945121404532 ()
  • 06945121404549 ()
  • 06945121404556 ()
  • 06945121404563 ()
  • 06945121404570 ()
  • 06945121404587 ()
  • 06945121404594 ()
  • 06945121404600 ()
  • 06945121404617 ()
  • 06945121404624 ()


  • General-purpose ultrasound imaging system

PLUG T2 - 18032919891072

Plug T2 5 cm is a three-dimensional plug on a macroporous round base with rigid tip, indicated for the treatment of inguinal and femoral hernia defects with open technique.
HERNIAMESH SRL
PT2/5
In Commercial Distribution

  • 18032919891072 ()


  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

MDHC - 06974669350193

Medical Face Shield
MDHC Life Technologies (Kunshan) Co., LTD.
5 pcs
In Commercial Distribution

  • 06974669350193 ()


  • Face splash shield, single-use

Capable - 06975867555212

No Description
Shanghai Kabu International Trade Co., Ltd
size 5
In Commercial Distribution

  • 06975867555212 ()
  • 16975867555219 ()


  • Infant nappy

T Testahead Multi-Drug Urine Test Dip Card - 06974246461618

No Description
Safecare Biotech (Hangzhou) Co., Ltd.
5 tests
In Commercial Distribution

  • 06974246461618 ()
MDP-1064

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Dental unit - 06974416450053

No Description
FOSHAN SAFETY MEDICAL EQUIPMENT CO.,LTD.
Mare.5
In Commercial Distribution

  • 06974416450053 ()


  • Dental delivery system instrument unit, electric

Exploro Vaginal Health pH Test Device - 06974246462288

No Description
Safecare Biotech (Hangzhou) Co., Ltd.
5 Tests
In Commercial Distribution

  • 06974246462288 ()
PH-6012

  • Vaginal pH screening IVD, kit, rapid colorimetric, clinical

Exploro Highly Sensitive Urine Drug Test (5-Panel) - 06974246462134

No Description
Safecare Biotech (Hangzhou) Co., Ltd.
5 tests
In Commercial Distribution

  • 06974246462134 ()
MDP-1054

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

T Testahead Multi-Drug Urine Test Dip Card - 06974246461595

No Description
Safecare Biotech (Hangzhou) Co., Ltd.
5 tests
In Commercial Distribution

  • 06974246461595 ()
MDP-1124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

FIRSTVIEW Fentanyl Urine Test Cassette - 06974246461496

No Description
Safecare Biotech (Hangzhou) Co., Ltd.
5 tests
In Commercial Distribution

  • 06974246461496 ()
FYL-1012

  • Fentanyl IVD, kit, rapid ICT, clinical

T Testahead Cotinine(COT) Urine Test Dipcard - 06974246461489

No Description
Safecare Biotech (Hangzhou) Co., Ltd.
5 tests
In Commercial Distribution

  • 06974246461489 ()
COT-1014

  • Nicotine/nicotine metabolite IVD, kit, rapid colorimetric, clinical

T Testahead Marijuana(THC) Urine Test Dipcard - 06974246461458

No Description
Safecare Biotech (Hangzhou) Co., Ltd.
5 tests
In Commercial Distribution

  • 06974246461458 ()
THC-1014

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

URINARY TRACT INFECTION TEST - 06974246461359

No Description
Safecare Biotech (Hangzhou) Co., Ltd.
5 tests
In Commercial Distribution

  • 06974246461359 ()
UTI-1021

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Vaginal PH Rapid Test Cassette - 06974246461342

No Description
Safecare Biotech (Hangzhou) Co., Ltd.
5 Tests
In Commercial Distribution

  • 06974246461342 ()
PH-6012

  • Vaginal pH screening IVD, kit, rapid colorimetric, clinical
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