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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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Surgical Gown_Set-In sleeve_Soft_Medium_W/ one hand towel_Sterile_32ea/cs
GRI Medical & Electronic Technology Co., Ltd.
i90-7010-S1
In Commercial Distribution

  • 26931918194582 ()
  • 16931918194585 ()


  • Surgical gown, single-use
Surgical Gown_Set-In sleeve_Soft_Small_W/ one hand towel_Sterile_22ea/cs
GRI Medical & Electronic Technology Co., Ltd.
i90-7000-S1
In Commercial Distribution

  • 26931918194414 ()
  • 16931918194417 ()


  • Surgical gown, single-use
Alleset Gown_no reinforcement_X-Large_35g SMS_With one towel_Handi-Bin_Non-Sterile_468ea/cs
GRI Medical & Electronic Technology Co., Ltd.
ALC90-2030-W1-HB
In Commercial Distribution

  • 06931918186255 ()
  • 16931918186252 ()


  • Surgical gown, single-use
Surgical Gown_i500_Non-Reinforced_XXL_W/ one hand towel_Extra Long_Sterile_24EA/CS
GRI Medical & Electronic Technology Co., Ltd.
i90-8042-S1
In Commercial Distribution

  • 26931918185566 ()
  • 16931918185569 ()


  • Surgical gown, single-use
Surgical Gown_Set-In sleeve_Standard_XL_W/ one hand towel_Non-sterile_378ea/cs
GRI Medical & Electronic Technology Co., Ltd.
i90-8030-W1-HB
In Commercial Distribution

  • 06931918184213 ()
  • 16931918184210 ()


  • Surgical gown, single-use
Surgical Gown_Set-In sleeve_Standard_Medium_W/ one hand towel_Sterile_32ea/cs
GRI Medical & Electronic Technology Co., Ltd.
i90-8010-S1
In Commercial Distribution

  • 26931918175499 ()
  • 16931918175492 ()


  • Surgical gown, single-use
Alleset Gown_no reinforcement_Large_35g SMS_With one towel_Handi-Bin_486ea/cs
GRI Medical & Electronic Technology Co., Ltd.
Model 90-2020-W1-HB
In Commercial Distribution

  • 06931918175273 ()
  • 16931918175270 ()


  • Surgical gown, single-use
Trials 11x14mm 7° w/one sided stop-10mm
Nuvasive, Inc.
Z700157-10
In Commercial Distribution

  • 00887517950291 ()


  • Spinal implant trial
Alpha Reline One MAS Reduction Imp Tray
Nuvasive, Inc.
ALPRELONEMASRED
In Commercial Distribution

  • 00195377050212 ()


  • Internal spinal fixation procedure kit, reusable
CLAMPS, STANDARD, (ONE PAIR) FOR PENNIG MINIFIXATOR
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568867077 ()
M411

  • External orthopaedic fixation system, reusable
MOBILE ANEROID W ONE PIECE CUFF MX
WELCH ALLYN, INC.
901091
In Commercial Distribution

  • 00732094342000 ()
420229

  • Aneroid manual sphygmomanometer
Integra® Jarit® Pomeroy Ear Syringe, With One Tapered Tip And One Bulbous Tip 4 oz
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
380362
In Commercial Distribution

  • M2743803621 ()
  • 10381780198215 ()
380-362

  • Ear canal irrigation syringe
Integra® Jarit® Pomeroy Ear Syringe, With One Tapered Tip And One Bulbous Tip 2 oz
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
380360
In Commercial Distribution

  • M2743803601 ()
  • 10381780198208 ()
380-360

  • Ear canal irrigation syringe
Cottle mallet, 7 1/2'', 12.0 oz. head weight, 32.0mm diameter, one flat end, one round end
AMBLER SURGICAL CORP.
Cottle mallet
In Commercial Distribution

  • 00190660213138 ()
141-096

  • Surgical mallet
obelisc center piece, Ø 20 mm, height 25-37 mm one fix end piece, one variable end piece
Ulrich GmbH & Co. KG
CS 2920-25
In Commercial Distribution

  • 04052536005581 ()
CS 2920-25

  • Vertebral body prosthesis
obelisc center piece, ø 20 mm, height 20-28 mm one fix end piece, one variable end piece
Ulrich GmbH & Co. KG
CS 2920-20
In Commercial Distribution

  • 04052536005574 ()
CS 2920-20

  • Vertebral body prosthesis
Coldpac Denture and Repair Acrylic Kit. Contains one 16 oz. powder (Clear) and one 8 oz. liquid.
BIRD-X, INC.
DK1608
In Commercial Distribution

  • 00706069343866 ()

  • Weight: 1 Pound
  • Total Volume: 8.0 Fluid Ounce


  • Dental appliance fabrication material, resin
Coldpac Denture and Repair Acrylic Kit. Contains one 16 oz. powder (Granular) and one 8 oz. liquid.
BIRD-X, INC.
DK1607
In Commercial Distribution

  • 00706069343767 ()

  • Total Volume: 8.0 Fluid Ounce
  • Weight: 1 Pound


  • Dental appliance fabrication material, resin
Visualase Anchor Bolt Driver Guide for ROSA ONE (1) Anchor Bolt Driver Guide for ROSA ONE Brain
FHC, INC.
9736542-00913
In Commercial Distribution

  • 00873263009130 ()
9736542

  • Neurological stereotactic surgery system
Castroviejo lacrimal dilator, 5 3/4'', double-ended, one needle-point end and one medium-taper end, round, knurled handle
AMBLER SURGICAL CORP.
Castroviejo lacrimal dilator
In Commercial Distribution

  • 00190660029548 ()
9889E

  • Lacrimal dilator, reusable
Cottle mallet, 7 1/2'', 12.0 oz. head weight, 32.0mm diameter, one flat end, one round end
AMBLER SURGICAL CORP.
Cottle mallet
In Commercial Distribution

  • 00190660100841 ()
41-096

  • Surgical mallet
Threaded anchor system Ø 6.5 mm with one Blue non-sliding suture and one White/Green sliding suture
S.B.M
Non-sliding BroadBand
In Commercial Distribution

  • 03760154007245 ()

  • Outer Diameter: 6.5 Millimeter
110026115

  • Tendon/ligament bone anchor, bioabsorbable
Threaded anchor system Ø 5.5 mm with one Blue non-sliding suture and one White/Green sliding suture
S.B.M
Non-sliding BroadBand
In Commercial Distribution

  • 03760154007238 ()

  • Outer Diameter: 5.5 Millimeter
110026114

  • Tendon/ligament bone anchor, bioabsorbable
Threaded anchor system Ø 4.5 mm with one Blue non-sliding suture and one White/Green sliding suture
S.B.M
Non-sliding BroadBand
In Commercial Distribution

  • 03760154007221 ()

  • Outer Diameter: 4.5 Millimeter
110026113

  • Tendon/ligament bone anchor, bioabsorbable
INnate Sterile Instrument Kit The kit contains two guide wires, one cannulated drill, and one cannulated driver.
Exsomed Corporation
EXINN914500
Not in Commercial Distribution

  • B487EXINN9145000 ()
EXINN914500

  • Orthopaedic implant driver
  • Orthopaedic guidewire, single-use
  • Cannulated surgical drill bit, single-use
  • Surgical depth gauge, single-use
INnate Sterile Instrument Kit The kit contains two guide wires, one cannulated drill, and one cannulated driver.
Exsomed Corporation
EXINN913600
Not in Commercial Distribution

  • B487EXINN9136000 ()
EXINN913600

  • Orthopaedic implant driver
  • Orthopaedic guidewire, single-use
  • Cannulated surgical drill bit, single-use
  • Surgical depth gauge, single-use
InFrame sterile instrument kit. The kit contains two step guide wires, one cannulated drill, one depth gauge
Exsomed Corporation
EXINF912000
Not in Commercial Distribution

  • B487EXINF9120000 ()
EXINF912000

  • Surgical depth gauge, single-use
  • Orthopaedic guidewire, single-use
  • Orthopaedic implant driver
HEALICOIL PK 5.5 MM SUTURE ANCHOR WITH ONE ULTRATAPE SUTURE BLUE AND ONE ULTRABRAID SUTURE No.2
Smith & Nephew, Inc.
72203983
In Commercial Distribution

  • 00885554032109 ()
72203983

  • Tendon/ligament bone anchor, non-bioabsorbable
HEALICOIL REGENESORB 5.5 MM SUTURE ANCHOR WITH ONE ULTRATAPE SUTURE BLUE AND ONE No.2 ULTRABRAID SUTURE
Smith & Nephew, Inc.
72203801
In Commercial Distribution

  • 00885554031430 ()
72203801

  • Tendon/ligament bone anchor, bioabsorbable
HEALICOIL REGENESORB 5.5 MM SUTURE ANCHOR WITH ONE ULTRATAPE SUTURE BLUE AND ONE No.2 ULTRABRAID SUTURE
Smith & Nephew, Inc.
72203708
In Commercial Distribution

  • 00885554031423 ()
72203708

  • Tendon/ligament bone anchor, bioabsorbable
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