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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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Invenio - 16931918194585

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

Invenio - 16931918194417

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 - 16931918186252

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

Invenio - 16931918185569

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

Invenio - 16931918184210

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

Invenio - 16931918175492

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 - 16931918175270

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

NuVasive - 00887517950291

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

  • 00887517950291 ()


  • Spinal implant trial

ReLine - 00195377050212

Alpha Reline One MAS Reduction Imp Tray
Nuvasive, Inc.
ALPRELONEMASRED
In Commercial Distribution

  • 00195377050212 ()


  • Internal spinal fixation procedure kit, reusable

PENNIG MINIFIXATOR - 18032568867077

CLAMPS, STANDARD, (ONE PAIR) FOR PENNIG MINIFIXATOR
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568867077 ()
M411

  • External orthopaedic fixation system, reusable

Welch Allyn, Inc. - 00732094342000

MOBILE ANEROID W ONE PIECE CUFF MX
WELCH ALLYN, INC.
901091
In Commercial Distribution

  • 00732094342000 ()
420229

  • Aneroid manual sphygmomanometer

Integra® Jarit® - 10381780198215

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® - 10381780198208

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

Ambler Value Line - 00190660213138

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™ vertebral body replacement - 04052536005581

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™ vertebral body replacement - 04052536005574

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

Yates Motloid Coldpac Denture and Repair Acrylic - 00706069343866

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

Yates Motloid Coldpac Denture and Repair Acrylic - 00706069343767

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 - 00873263009130

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

Ambler Surgical - 00190660029548

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

Ambler Surgical - 00190660100841

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

ComposiTCP™ - 03760154007245

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

ComposiTCP™ - 03760154007238

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

ComposiTCP™ - 03760154007221

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 Instrument Kit - B487EXINN9145000

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 Instrument Kit - B487EXINN9136000

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 Instrument Kit - B487EXINF9120000

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 - 00885554032109

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 - 00885554031430

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 - 00885554031423

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

HEALICOIL REGENESORB - 00885554031409

HEALICOIL REGENESORB 4.75 MM SUTURE ANCHOR WITH ONE ULTRATAPE SUTURE BLUE AND ONE No.2 ULTRABRAID SUTURE
Smith & Nephew, Inc.
72203705
In Commercial Distribution

  • 00885554031409 ()
72203705

  • Tendon/ligament bone anchor, bioabsorbable

Spike Adapter - 10816203022469

One spike to one male luer with 50cm DMSO resistant tubing and pinch clamp, case of 50
ORIGEN BIOMEDICAL, INC.
S-M50C
Not in Commercial Distribution

  • 10816203022469 ()
  • 20816203022466 ()


  • Blood transfer set

Spike Adapter - 10816203020267

One spike to one male luer with 50cm DMSO resistant tubing and pinch clamp, case of 50
ORIGEN BIOMEDICAL, INC.
S-M50
In Commercial Distribution

  • 20816203020264 ()
  • 10816203020267 ()


  • Blood transfer set

Spike Adapter - 10816203020250

One spike to one male luer with 10cm DMSO resistant tubing and pinch clamp, case of 50
ORIGEN BIOMEDICAL, INC.
S-M10
Not in Commercial Distribution

  • 10816203020250 ()
  • 20816203020257 ()


  • Blood transfer set

Spike Adapter - 10816203020243

One spike to one female luer with 50cm DMSO resistant tubing and pinch clamp, case of 50
ORIGEN BIOMEDICAL, INC.
S-F50
In Commercial Distribution

  • 10816203020243 ()
  • 20816203020240 ()


  • Blood transfer set

Spike Adapter - 10816203020236

One spike to one female luer with 10cm DMSO resistant tubing and pinch clamp, case of 50
ORIGEN BIOMEDICAL, INC.
S-F10
In Commercial Distribution

  • 10816203020236 ()
  • 20816203020233 ()


  • Blood transfer set

Spike Adapter - 10816203021929

One spike to one female luer with 15cm DMSO resistant tubing and pinch clamp, case of 50
ORIGEN BIOMEDICAL, INC.
S-F15
Not in Commercial Distribution

  • 10816203021929 ()
  • 20816203021926 ()


  • Blood transfer set

SMITHWICK Carotid Shunt - 00858764006185

Two 15cm, tapered, carotid shunts. One 1408 shunt (14 Fr. to 8 Fr.) and one 1209 shunt (12 Fr. to 9 Fr.), together in one peel pack
Implantable Devices
Twin Pack
Not in Commercial Distribution

  • 00858764006185 ()
Twin Pack

  • Carotid artery shunt

Thrombin JMI - 5,000 IU Epistaxis Kit - 10360793205059

Thrombin JMI - 5,000 IU Epistaxis Kit w/5 mL diluent; Contents - Sterile unless tray is opened or damaged: one vial 5,000 units thrombin, one vial 5 mL diluent, one sterile disposable syringe, one nasal drug delivery device
Pfizer H.C.P. Corporation
NDC 60793-205-05
In Commercial Distribution

  • 10360793205059 ()

  • Total Volume: 10 Milliliter
  • Syringe size


  • General surgical procedure kit, medicated

SET Aspirex™ S 6F 110cm - 07640142811312

The Aspirex™ S Thrombectomy Catheter Set is composed of one Aspirex™ S Thrombectomy Catheter (gauge 6F; length 110cm), one Aspirex™ S Guidewire (0.018” diameter; 270cm in length), one collecting bag, and one sterile drape.
Straub Medical AG
80324
In Commercial Distribution

  • 07640142811312 ()

  • Catheter Gauge: 6 French
  • Catheter Working Length: 110 Centimeter
80324

  • Thrombectomy rotational catheter

Tatum Surgical/Hand Tool - 00083208120046

Hand Tool #12 Driver for 3.0mm one piece Implant (CB)
Suncoast Dental, Inc
Hand Tool / HT.12
In Commercial Distribution

  • 00083208120046 ()

  • Hand tool #12 Driver for 3.0mm one piece Implants (CB)
HT.12

  • Dental implant system

Tatum Surgical/Hand Tool - 00083208250040

Hand Tool #25 Driver for 8.0mm one piece Implant (CB)
Suncoast Dental, Inc
Hand Tool / HT.25
In Commercial Distribution

  • 00083208250040 ()

  • Hand Tool #25 Driver for 8.0mm one piece Implant (CB)
HT.25

  • Dental implant system

Tatum Surgical/Hand Tool - 00083208240041

Hand Tool #24 Driver for 7.0mm one piece Implant (CB)
Suncoast Dental, Inc
Hand Tool / HT.24
In Commercial Distribution

  • 00083208240041 ()

  • Hand Tool #24 Driver for 7.0mm one piece Implant (CB)
HT.24

  • Dental implant system

Tatum Surgical/Hand Tool - 00083208230042

Hand Tool #23 Driver for 6.0mm one piece Implant (CB)
Suncoast Dental, Inc
Hand Tool / HT.23
In Commercial Distribution

  • 00083208230042 ()

  • Hand Tool #23 Driver for 6.0mm one piece Implant (CB)
HT.23

  • Dental implant system

Tatum Surgical/Hand Tool - 00083208180040

Hand Tool #18 Driver for 5.0mm one piece Implant (CB)
Suncoast Dental, Inc
Hand Tool / HT.18
In Commercial Distribution

  • 00083208180040 ()

  • Hand tool #18 Driver for 5.0mm one piece Implants (CB)
HT.18

  • Dental implant system

Tatum Surgical/Hand Tool - 00083208170041

Hand Tool #17 Driver for 4.0 and 4.5mm one piece Implant (CB)
Suncoast Dental, Inc
Hand Tool / HT.17
In Commercial Distribution

  • 00083208170041 ()

  • Hand tool #17 Driver for 4.0-4.5mm one piece Implants (CB)
HT.17

  • Dental implant system

Tatum Surgical/Hand Tool - 00083208150043

Hand Tool #15 Driver for 3.5mm one piece Implant (CB)
Suncoast Dental, Inc
Hand Tool / HT.15
In Commercial Distribution

  • 00083208150043 ()

  • Hand tool #15 Driver for 3.5mm one piece Implants (CB)
HT.15

  • Dental implant system

Thrombin JMI - 5,000 IU Vial Syringe Spray Kit - 10360793705054

Thrombin JMI - 5,000 IU Vial Syringe Spray Kit w/5 mL diluent; Contents - Sterile unless tray is opened or damaged: One vial 5,000 units thrombin, one vial 5 mL diluent, one sterile disposable syringe, one sterile spray tip.
Pfizer H.C.P. Corporation
NDC 60793-705-05
In Commercial Distribution

  • 10360793705054 ()

  • Syringe size
  • Total Volume: 10 Milliliter


  • General surgical procedure kit, medicated

Thrombin JMI - 20,000 IU Vial Syringe Spray Kit - 10360793217229

Thrombin JMI - 20,000 IU Vial Syringe Spray Kit w/20 mL diluent; Contents - Sterile unless tray is opened or damaged: One vial 20,000 units thrombin, one vial 20 mL diluent, one sterile disposable syringe, one sterile spray tip.
Pfizer H.C.P. Corporation
NDC 60793-217-22
In Commercial Distribution

  • 10360793217229 ()

  • Syringe size
  • Total Volume: 20 Milliliter


  • General surgical procedure kit, medicated

Thrombin JMI - 20,000 IU Vial Pump spray Kit - 10360793217212

Thrombin JMI - 20,000 IU Vial Pump spray Kit w/20 mL diluent; Contents - Sterile unless tray is opened or damaged: One vial 20,000 units thrombin, one vial 20 mL diluent, one spray pump and actuator, one transfer device.
Pfizer H.C.P. Corporation
NDC 60793-217-21
In Commercial Distribution

  • 10360793217212 ()

  • Total Volume: 20 Milliliter
  • Syringe size


  • General surgical procedure kit, medicated
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