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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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Epredia - 00850037343010

No Description
NEW ERIE SCIENTIFIC LLC
Microscope Slide Non Adhesion
In Commercial Distribution

  • 00850037343010 ()
  • 10850037343017 ()
AF00004432E04MNZ51

  • General specimen microscopy slide IVD, single-use

M-Close Kit - 00850009417213

The device is a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall which is non-powered, hand-held, and hand-manipulated, intended to be used in various general surgical procedures. The device includes a ligature carrier pathway, needle guide, two needles, reference plane T-Bar, and a guidewire. The handle of the device provides two diametrically opposed enclosed guideways for the advancement and retraction of the needles under manual control of a plunger located at the proximal end of the device. As part of the M-Close convenience kit, a Nerve Block Needle is included for the administration of local anesthetic agents to provide regional and local anesthesia. A Telfa Antimicrobial, non-Adherent Pad is provided in the kit for use as a primary dressing for the surgical incision as well as a slip-tip syringe.
New Wave Endo-Surgery Inc.
27-108
In Commercial Distribution

  • 00850009417220 ()
  • 00850009417213 ()
  • 00850009417237 ()
  • 00850009417244 ()

  • Outer Diameter: 12 Millimeter
27-108

  • Suturing unit, single-use

M-Close Kit - 00850009417022

The device is a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall which is non-powered, hand-held, and hand-manipulated, intended to be used in various general surgical procedures. The device includes a ligature carrier pathway, needle guide, two needles, reference plane T-Bar, and a guidewire. The handle of the device provides two diametrically opposed enclosed guideways for the advancement and retraction of the needles under manual control of a plunger located at the proximal end of the device.As part of the M-Close convenience kit, a Nerve Block Needle is included for the administration of local anesthetic agents to provide regional and local anesthesia. A Telfa Antimicrobial, non-Adherent Pad is also provided in the kit for use as a primary dressing for the surgical incision.
New Wave Endo-Surgery Inc.
27-101
In Commercial Distribution

  • 00850009417053 ()
  • 00850009417022 ()
  • 00850009417060 ()
  • 00850009417107 ()

  • Outer Diameter: 12 Millimeter
27-101

  • Suturing unit, single-use

NA - 00851830007321

Air Force 1000 P.U. US NSM
NEW SOURCE MEDICAL, LLC
S2002-3141
In Commercial Distribution

  • 00851830007321 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007314

NSM 1400 with male coupling Cover QLT- 1p
NEW SOURCE MEDICAL, LLC
S2816-A040
In Commercial Distribution

  • 10851830007311 ()
  • 00851830007314 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007307

NSM 3000 with male coupling Cover QLT - 1p
NEW SOURCE MEDICAL, LLC
S2816-A030
In Commercial Distribution

  • 10851830007304 ()
  • 00851830007307 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007291

NSM LB Cover QLT -1p
NEW SOURCE MEDICAL, LLC
S2816-A020
In Commercial Distribution

  • 10851830007298 ()
  • 00851830007291 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007284

NSM LP Cover QLT -1p
NEW SOURCE MEDICAL, LLC
S2816-A010
In Commercial Distribution

  • 10851830007281 ()
  • 00851830007284 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007277

Delta Force P.U. US NSM
NEW SOURCE MEDICAL, LLC
S2203-3131
In Commercial Distribution

  • 00851830007277 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007260

Delta Force Pro P.U. US NSM
NEW SOURCE MEDICAL, LLC
S2101-3081
In Commercial Distribution

  • 00851830007260 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007253

Delta Force Pro ST M-set 36'' x 84'' QLT NSM
NEW SOURCE MEDICAL, LLC
S2101-2250
In Commercial Distribution

  • 00851830007253 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007246

Delta Force Pro ST M-set 36'' x 80'' QLT NSM
NEW SOURCE MEDICAL, LLC
S2101-2240
In Commercial Distribution

  • 00851830007246 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007239

Delta Force Pro IB M-set 36'' x 84'' QLT NSM
NEW SOURCE MEDICAL, LLC
S2101-2230
In Commercial Distribution

  • 00851830007239 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007222

Delta Force Pro IB M-set 36'' x 80'' QLT NSM
NEW SOURCE MEDICAL, LLC
S2101-2220
In Commercial Distribution

  • 00851830007222 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007215

Air Force 1000 P.U. US NSM
NEW SOURCE MEDICAL, LLC
S2002-3131
In Commercial Distribution

  • 00851830007215 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007208

NSM ST Cover 42'' x 84'' QLT -1p
NEW SOURCE MEDICAL, LLC
S2001-A560
In Commercial Distribution

  • 10851830007205 ()
  • 00851830007208 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007192

NSM IB Cover 42'' x 84'' QLT -1p
NEW SOURCE MEDICAL, LLC
S2001-A550
In Commercial Distribution

  • 00851830007192 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007185

NSM ST Cover 48'' x 84'' QLT -1p
NEW SOURCE MEDICAL, LLC
S2001-A540
In Commercial Distribution

  • 10851830007182 ()
  • 00851830007185 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007178

NSM IB Cover 48'' x 84'' QLT -1p
NEW SOURCE MEDICAL, LLC
S2001-A530
In Commercial Distribution

  • 00851830007178 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007161

NSM ST Cover 48'' x 80'' QLT -1p
NEW SOURCE MEDICAL, LLC
S2001-A520
In Commercial Distribution

  • 10851830007168 ()
  • 00851830007161 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007154

NSM ST Cover 36'' x 84'' QLT -1p
NEW SOURCE MEDICAL, LLC
S2001-A510
In Commercial Distribution

  • 10851830007151 ()
  • 00851830007154 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007147

NSM ST Cover 36'' x 80'' QLT -1p
NEW SOURCE MEDICAL, LLC
S2001-A500
In Commercial Distribution

  • 10851830007144 ()
  • 00851830007147 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007130

NSM IB Cover 48'' x 80'' QLT -1p
NEW SOURCE MEDICAL, LLC
S2001-A490
In Commercial Distribution

  • 00851830007130 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007123

NSM IB Cover 36'' x 84'' QLT -1p
NEW SOURCE MEDICAL, LLC
S2001-A480
In Commercial Distribution

  • 00851830007123 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007116

NSM IB Cover 36'' x 80'' QLT -1p
NEW SOURCE MEDICAL, LLC
S2001-A470
In Commercial Distribution

  • 00851830007116 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007109

NSM ST Cover 54'' x 80'' QLT -1p
NEW SOURCE MEDICAL, LLC
S2001-A580
In Commercial Distribution

  • 10851830007106 ()
  • 00851830007109 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007093

NSM IB Cover 54'' x 80'' QLT -1p
NEW SOURCE MEDICAL, LLC
S2001-A570
In Commercial Distribution

  • 00851830007093 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007086

Air Force 1000 ST M-set 54'' x 80'' QLT NSM
NEW SOURCE MEDICAL, LLC
S2001-2560
In Commercial Distribution

  • 00851830007086 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007079

Air Force 1000 IB M-set 54'' x 80'' QLT NSM
NEW SOURCE MEDICAL, LLC
S2001-2550
In Commercial Distribution

  • 00851830007079 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007062

Air Force 1000 ST M-set 42'' x 84'' QLT NSM
NEW SOURCE MEDICAL, LLC
S2001-2540
In Commercial Distribution

  • 00851830007062 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007055

Air Force 1000 ST M-set 48'' x 84'' QLT NSM
NEW SOURCE MEDICAL, LLC
S2001-2530
In Commercial Distribution

  • 00851830007055 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007048

Air Force 1000 ST M-set 36'' x 84'' QLT NSM
NEW SOURCE MEDICAL, LLC
S2001-2520
In Commercial Distribution

  • 00851830007048 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007031

Air Force 1000 ST M-set 36'' x 80'' QLT NSM
NEW SOURCE MEDICAL, LLC
S2001-2510
In Commercial Distribution

  • 00851830007031 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007024

Air Force 1000 IB M-set 48'' x 80'' QLT NSM
NEW SOURCE MEDICAL, LLC
S2001-2500
In Commercial Distribution

  • 00851830007024 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007017

Air Force 1000 IB M-set 36'' x 84'' QLT NSM
NEW SOURCE MEDICAL, LLC
S2001-2490
In Commercial Distribution

  • 00851830007017 ()


  • Alternating-pressure bed mattress overlay system

NA - 00851830007000

Air Force 1000 IB M-set 36'' x 80'' QLT NSM
NEW SOURCE MEDICAL, LLC
S2001-2480
In Commercial Distribution

  • 00851830007000 ()


  • Alternating-pressure bed mattress overlay system

AHIP Internal Trigger Point Wand - 00862945000404

Therapeutic massager to internally massage trigger points in the pelvic floor musculature.
NEW PELVIC PAIN TECHNOLOGIES
1112
In Commercial Distribution

  • 00862945000404 ()


  • Pelvic floor internal manual massager

CoolTouch - 00859932006327

Pullback Device
NEW STAR LASERS, INC.
7435-0254
Not in Commercial Distribution

  • 00859932006327 ()


  • General/multiple surgical solid-state laser system

CoolTouch - 00859932006303

Cryogen Cooling
NEW STAR LASERS, INC.
7435-0200
Not in Commercial Distribution

  • 10859932006300 ()
  • 00859932006303 ()


  • General/multiple surgical solid-state laser system

CoolTouch - 00859932006266

Pullback Device
NEW STAR LASERS, INC.
7435-0060
Not in Commercial Distribution

  • 00859932006266 ()


  • General/multiple surgical solid-state laser system
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