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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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National Biological Corporation - 00816878020534

No Description
NATIONAL BIOLOGICAL CORPORATION
UHU-528
In Commercial Distribution

  • 00816878020534 ()


  • Ultraviolet phototherapy unit, professional

National Biological Corporation - 00816878020527

No Description
NATIONAL BIOLOGICAL CORPORATION
UHU-526
In Commercial Distribution

  • 00816878020527 ()


  • Ultraviolet phototherapy unit, professional

National Biological Corporation - 00816878020510

No Description
NATIONAL BIOLOGICAL CORPORATION
UHU-524
In Commercial Distribution

  • 00816878020510 ()


  • Ultraviolet phototherapy unit, professional

National Biological Corporation - 00816878020503

No Description
NATIONAL BIOLOGICAL CORPORATION
UHU-522
In Commercial Distribution

  • 00816878020503 ()


  • Ultraviolet phototherapy unit, professional

National Biological Corporation - 00816878020497

No Description
NATIONAL BIOLOGICAL CORPORATION
UHU-520
In Commercial Distribution

  • 00816878020497 ()


  • Ultraviolet phototherapy unit, professional

National Biological Corporation - 00816878020480

No Description
NATIONAL BIOLOGICAL CORPORATION
UHU-518
In Commercial Distribution

  • 00816878020480 ()


  • Ultraviolet phototherapy unit, professional

National Biological Corporation - 00816878020473

No Description
NATIONAL BIOLOGICAL CORPORATION
UHU-516
In Commercial Distribution

  • 00816878020473 ()


  • Ultraviolet phototherapy unit, professional

National Biological Corporation - 00816878020466

No Description
NATIONAL BIOLOGICAL CORPORATION
UHU-514
In Commercial Distribution

  • 00816878020466 ()


  • Ultraviolet phototherapy unit, professional

National Biological Corporation - 00816878020459

No Description
NATIONAL BIOLOGICAL CORPORATION
UHU-512
In Commercial Distribution

  • 00816878020459 ()


  • Ultraviolet phototherapy unit, professional

National Biological Corporation - 00816878020442

No Description
NATIONAL BIOLOGICAL CORPORATION
UHU-510
In Commercial Distribution

  • 00816878020442 ()


  • Ultraviolet phototherapy unit, professional

National Biological Corporation - 00816878020428

No Description
NATIONAL BIOLOGICAL CORPORATION
UHU-324
In Commercial Distribution

  • 00816878020428 ()


  • Ultraviolet phototherapy unit, professional

National Biological Corporation - 00816878020404

No Description
NATIONAL BIOLOGICAL CORPORATION
UHU-318
In Commercial Distribution

  • 00816878020404 ()


  • Ultraviolet phototherapy unit, professional

National Biological Corporation - 00816878020381

No Description
NATIONAL BIOLOGICAL CORPORATION
UHU-312
In Commercial Distribution

  • 00816878020381 ()


  • Ultraviolet phototherapy unit, professional

National Biological Corporation - 00816878020367

No Description
NATIONAL BIOLOGICAL CORPORATION
UAB-102
In Commercial Distribution

  • 00816878020367 ()


  • Ultraviolet phototherapy unit, professional

V30 Console - 07290016746006

V30 Console
VIORA LTD
VTL40000
In Commercial Distribution

  • 07290016746006 ()
VTL40000

  • Multi-modality skin surface treatment system generator

Venus Versa - 07290016540383

The Venus Versa system is a multi-application device intended to be used in aesthetic and cosmetic procedures.
VENUS CONCEPT LTD
VE102407
In Commercial Distribution

  • 07290016540499 ()
  • 07290016540383 ()


  • Multi-modality skin surface treatment system generator

ZHEONE - 06977620360026

The Q-Switched Nd:Yag laser is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, nevus, and birthmark; and the removal of black or blue tattoos.
Hebei Zhemai Technology Co., Ltd.
FQ-L08
In Commercial Distribution

  • 06977620360026 ()


  • Multi-modality skin surface treatment system generator

SUPERLASER - 06973537443005

No Description
Beijing Superlaser Technology Co., Ltd.
SL-NY602
In Commercial Distribution

  • 06973537443005 ()


  • Multi-modality skin surface treatment system generator

Huamei - 06973512860612

No Description
Shandong Huamei Technology Co.,Ltd.
HM-YL900
In Commercial Distribution

  • 06973512860612 ()


  • Multi-modality skin surface treatment system generator

Refurbished Applicator Frax 1940 - 00817495025087

Refurbished Applicator Frax 1940
Candela Corporation
FIN101207
In Commercial Distribution

  • 00817495025087 ()


  • Multi-modality skin surface treatment system generator

308nm Excimer System - 06971777450036

308nm Excimer System is an ultratraviolet light system designed to be used in Dermatological practice for the treatment of psoriasis and vitiligo. The lamp is axenon-chloride excimer lamp which utilizes a XeCl gas mixture to generate specific ultraviolet light at wavelength of 308 nm. It displays the treatment parameters. Users can set the device and fluence on the control touch screen and determine the machine's state and function under the help of colour-coded indicator light.
Chongqing Peninsula Medical Technology Co., Ltd.
XECL-308C, XECL-308D
In Commercial Distribution

  • 06971777450036 ()


  • Ultraviolet phototherapy unit, professional

UVBioTek - B343B4000

Phototherapy Unit. UVB Narrowband. 4 connected panels, attached to a wall, wrap around patient. 40 lamps, each 72" in height. Clinic use only.
Medtek Lighting Corporation
4000B
In Commercial Distribution

  • B343B4000 ()

  • Area/Surface Area: 5740 Square inch
  • Weight: 550 Pound
4000B

  • Ultraviolet phototherapy unit, professional

Biowave Noninvasive Electrodes - 00859911006089

Biowave Noninvasive Electrode - B-Set
BIOWAVE CORPORATION
MK78560 - BWEN01-B
In Commercial Distribution

  • 20859911006083 ()
  • 10859911006086 ()
  • 00859911006089 ()


  • Transcutaneous electrical stimulation electrode, single-use

Biowave Percutaneous Electrodes - 00859911006003

Biowave Percutaneous Electrode Set - B
BIOWAVE CORPORATION
MK78505 - BWEP01-B
In Commercial Distribution

  • 20859911006007 ()
  • 10859911006000 ()
  • 00859911006003 ()


  • Analgesic PENS system probe, single-use

Skytron - 10841736117245

3 Inch 3pc PADSET BLUE: 6001k 6002&B 6500&HD 6600&B
SKYTRON LLC
1-011-02-3B
In Commercial Distribution

  • 10841736117245 ()
1-011-02-3B

  • Operating table patient pressure distribution pad, reusable

Skytron - 10841736117221

3 Inch BK/ ST SECTION 6001k 6002&B 6500&HD 6600&B
SKYTRON LLC
1-011-02-32
In Commercial Distribution

  • 10841736117221 ()
1-011-02-32

  • Operating table patient pressure distribution pad, reusable

N/A - 00840329809041

B&B E-P ELECTROSURGICAL DISSECTOR; 14 5''(36.5CM), STRAIGHT SHAFT, ANGLED TIP
BLACK & BLACK SURGICAL, INC.
B65228
In Commercial Distribution

  • 00840329809041 ()
B65228

  • Endoscopic electrosurgical electrode, monopolar, reusable

N/A - 00840329808969

B&B ENDOFOREHEAD FENESTRATED 12X23 MM CANNULA SINGLE STOP-COCK FOR 5MM SCOPE
BLACK & BLACK SURGICAL, INC.
B65114
In Commercial Distribution

  • 00840329808969 ()
B65114

  • Suction system catheter, general-purpose

N/A - 00840329808952

B&B ENDOFOREHEAD FENESTRATED 7X17 MM CANNULA SINGLE STOP-COCK FOR 5MM SCOPE
BLACK & BLACK SURGICAL, INC.
B65113
In Commercial Distribution

  • 00840329808952 ()
B65113

  • Suction system catheter, general-purpose

SpO2.COM® NRC-SL2 Spacelabs Replacement Cable - 00843997001434

No Description
MASIMO CORPORATION
2335
In Commercial Distribution

  • 00843997001434 ()


  • Electrical-only medical device connection cable, reusable

SpO2.COM® NRC-P8 Patient Cable, 3M - 00843997001427

No Description
MASIMO CORPORATION
1949
In Commercial Distribution

  • 00843997001427 ()


  • Electrical-only medical device connection cable, reusable

SpO2.COM® NRC-SL Spacelabs Replacement Cable - 00843997001410

No Description
MASIMO CORPORATION
1900
In Commercial Distribution

  • 00843997001410 ()


  • Electrical-only medical device connection cable, reusable

SpO2.COM® pediatric SpO2 disposable sensor - 10843997000489

No Description
MASIMO CORPORATION
1775
In Commercial Distribution

  • 10843997000489 ()
  • 00843997000482 ()


  • Pulse oximeter probe, single-use

SpO2.COM® Infant SpO2 disposable sensor - 10843997000472

No Description
MASIMO CORPORATION
1777
In Commercial Distribution

  • 10843997000472 ()
  • 00843997000475 ()


  • Pulse oximeter probe, single-use

SpO2.COM® adult SpO2 disposable sensor - 10843997000465

No Description
MASIMO CORPORATION
1774
In Commercial Distribution

  • 10843997000465 ()
  • 00843997000468 ()


  • Pulse oximeter probe, single-use

LIGHTSonic B UBM - 00853386006285

No Description
LIGHTMED USA INC
US0000
In Commercial Distribution

  • 00853386006285 ()


  • Ophthalmic ultrasound imaging system

B Medical Systems - 05450104551512

Ultra Low Freezer
B Medical Systems SARL
U201
In Commercial Distribution

  • 05450104551512 ()
991.8643.**

  • Ultralow-temperature laboratory freezer

B Medical Systems - 05450104548390

Pharmacy refrigerator/ freezer
B Medical Systems SARL
PF260
In Commercial Distribution

  • 05450104548390 ()
991.8346.**

  • Pharmacy refrigerator/freezer, mains-powered

B Medical Systems - 05450104548383

Laboratory refrigerator/ freezer
B Medical Systems SARL
LF260
In Commercial Distribution

  • 05450104548383 ()
991.8346.**

  • Laboratory refrigerator/freezer

B Medical Systems - 05450104548376

Blood refrigerator/ Plasma freezer
B Medical Systems SARL
BF261
In Commercial Distribution

  • 05450104548376 ()
991.8346.**

  • Blood refrigerator/freezer

B Medical Systems - 05450104548369

Pharmacy refrigerator
B Medical Systems SARL
P380
In Commercial Distribution

  • 05450104548369 ()
991.8336.**

  • Pharmacy refrigerator

B Medical Systems - 05450104548352

Laboratory refrigerator
B Medical Systems SARL
L380
In Commercial Distribution

  • 05450104548352 ()
991.8336.**

  • Laboratory refrigerator, basic

B Medical Systems - 05450104548345

Blood storage refrigerator
B Medical Systems SARL
B381
In Commercial Distribution

  • 05450104548345 ()
991.8336.**

  • Blood refrigerator

B Medical Systems - 05450104548338

Pharmacy refrigerator
B Medical Systems SARL
P290
In Commercial Distribution

  • 05450104548338 ()
991.8326.**

  • Pharmacy refrigerator

B Medical Systems - 05450104548321

Laboratory refrigerator
B Medical Systems SARL
L290
In Commercial Distribution

  • 05450104548321 ()
991.8326.**

  • Laboratory refrigerator, basic

B Medical Systems - 05450104548314

Blood storage refrigerator
B Medical Systems SARL
B291
In Commercial Distribution

  • 05450104548314 ()
991.8326.**

  • Blood refrigerator

B Medical Systems - 05450104548307

Pharmacy refrigerator
B Medical Systems SARL
P130
In Commercial Distribution

  • 05450104548307 ()
991.8316.**

  • Pharmacy refrigerator

B Medical Systems - 05450104548291

Laboratory refrigerator
B Medical Systems SARL
L130
In Commercial Distribution

  • 05450104548291 ()
991.8316.**

  • Laboratory refrigerator, basic

B Medical Systems - 05450104548284

Blood storage refrigerator
B Medical Systems SARL
B131
In Commercial Distribution

  • 05450104548284 ()
991.8316.**

  • Blood refrigerator

B Medical Systems - 05450104548277

Pharmacy refrigerator
B Medical Systems SARL
P55
In Commercial Distribution

  • 05450104548277 ()
991.8306.**

  • Pharmacy refrigerator
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