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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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N/A - 00840329808549

LAMBOTTE MINI OSTEOTOME; 5"(12.5CM), STRAIGHT 4MM(5/16")
BLACK & BLACK SURGICAL, INC.
B64101
In Commercial Distribution

  • 00840329808549 ()
B64101

  • Orthopaedic osteotome

QUANTUM - 03701337602260

QUANTUM Fixed Insert Implant Size 5 Right 5 mm
IN2BONES
M50 SU155
In Commercial Distribution

  • 03701337602260 ()

  • Length: 40.57 Millimeter
  • Length: 34 Millimeter
M50 SU155

  • Fixed-bearing total ankle prosthesis

QUANTUM - 03701337602185

QUANTUM Fixed Insert Implant Size 5 Left 5 mm
IN2BONES
M50 SU255
In Commercial Distribution

  • 03701337602185 ()

  • Length: 40.57 Millimeter
  • Length: 34 Millimeter
M50 SU255

  • Fixed-bearing total ankle prosthesis

Budde® - 10381780253204

Budde® 13/64” – 5/8” x 5” Tapered
INTEGRA LIFESCIENCES CORPORATION
438A1154C
In Commercial Distribution

  • M268438A1154C1 ()
  • 10381780253204 ()

  • 5" Length x 0.5" Width x 0.05" Height
438A1154C

  • Neurosurgical retraction system, brain

BOSS Instruments - 00888515204614

Kirschner Bow, medium, 5 3/4" 5" max opening
BOSS INSTRUMENTS, LTD., INC.
79-0340
In Commercial Distribution

  • 00888515204614 ()
79-0340

  • Wire twister

Surgical Direct - B382SD9340861050

5 5/8" Grooved Director Tongue Tie, Plain Point
Surgical Direct, Inc.
SD934086105
In Commercial Distribution

  • B382SD9340861050 ()
SD934086105

  • Eye muscle hook, reusable

Dental Dams - 10732224002177

Dental Dam Natural Latex, Unflavored, 5" x 5", Heavy
CROSSTEX INTERNATIONAL, INC.
19101
In Commercial Distribution

  • 50732224002175 ()
  • 10732224002177 ()
  • 00732224002170 ()


  • Rubber dam, Hevea-latex

Dental Dams - 10732224002160

Dental Dams, Natural Latex, Unflavored 5" x 5", Medium
CROSSTEX INTERNATIONAL, INC.
19100
In Commercial Distribution

  • 50732224002168 ()
  • 10732224002160 ()
  • 00732224002163 ()


  • Rubber dam, Hevea-latex

Dental Dams - 10732224002153

Dental Dam Natural Latex, Unflavored, 5" x 5" Thin
CROSSTEX INTERNATIONAL, INC.
19102
In Commercial Distribution

  • 50732224002151 ()
  • 10732224002153 ()
  • 00732224002156 ()


  • Rubber dam, Hevea-latex

Dental Dams - 10732224002146

Dental Dam Natural Latex, Mint, 5" x 5", Heavy
CROSSTEX INTERNATIONAL, INC.
19201
In Commercial Distribution

  • 50732224002144 ()
  • 10732224002146 ()
  • 00732224002149 ()


  • Rubber dam, Hevea-latex

Dental Dams - 10732224002139

Dental Dam Natural Latex, Mint, 5" x 5", Medium
CROSSTEX INTERNATIONAL, INC.
19200
In Commercial Distribution

  • 50732224002137 ()
  • 10732224002139 ()
  • 00732224002132 ()


  • Rubber dam, Hevea-latex

Dental Dams - 10732224002122

Dental Dam Natural Latex, Mint, 5" x 5", Thin
CROSSTEX INTERNATIONAL, INC.
19202
In Commercial Distribution

  • 50732224002120 ()
  • 10732224002122 ()
  • 00732224002125 ()


  • Rubber dam, Hevea-latex

Brasseler USA - 00887919680550

CG4/5 GREG 4/5 COMP #2 HDL 1P
Peter Brasseler Holdings, LLC
5023258U0
In Commercial Distribution

  • 00887919680550 ()


  • Dental restoration carver, resin

MSI - 00810130204724

Harrington Blade 2 1/2" x 5 5/8"
Modern Surgical Instruments LLC
62-6600
In Commercial Distribution

  • 00810130204724 ()


  • Surgical retractor/retraction system blade, reusable

MSI - 00810130205721

Hoke Osteo 5 1/4" Cvd. 5/16", 8mm
Modern Surgical Instruments LLC
46-0703
In Commercial Distribution

  • 00810130205721 ()


  • Orthopaedic osteotome

Norfentanyl DAU Calibrator, Cutoff Calibrator - B07603130

5 mL/bottle. Concentration: 5 ng/mL of Norfentanyl.
LIN-ZHI INTERNATIONAL, INC.
0313
In Commercial Distribution

  • B07603130 ()
0313

  • Fentanyl IVD, calibrator

Sklar® - 10649111137518

HOKE OSTEO CVD 5 1/2 5/8"WIDE
SKLAR CORPORATION
40-6982
In Commercial Distribution

  • 10649111137518 ()


  • Surgical gouge

BOSS Instruments - 00888515228566

Curette, large, 2.25x3mm serr,ang 35deg, 5 5/8"
BOSS INSTRUMENTS, LTD., INC.
90-3215
In Commercial Distribution

  • 00888515228566 ()
90-3215

  • Endaural surgical curette, reusable

Budde® - 10381780537762

Budde® 13/64" – 5/8" x 5" Tapered
INTEGRA LIFESCIENCES CORPORATION
438A1154C
In Commercial Distribution


  • 5" Length x 0.5" Width x 0.05" Height
438A1154C

  • Neurosurgical retraction system, brain

Surgical Direct - B382SD934115560

5” Bowman Lacrimal Probe, Size 5/6, Bulbous Tip
Surgical Direct, Inc.
SD93411556
In Commercial Distribution

  • B382SD934115560 ()
SD93411556

  • Eye muscle hook, reusable

Surgical Direct - B382SD920598050

5 1/2 inch Wagner Ear Hook, Size 5
Surgical Direct, Inc.
SD92059805
In Commercial Distribution

  • B382SD920598050 ()
SD92059805

  • Ear excavator

BOSS Instruments - 00888515035485

Dbl Prong Micro Hook, sharp, 2mm, 5 5/8"
BOSS INSTRUMENTS, LTD., INC.
18-5200
In Commercial Distribution

  • 00888515035485 ()
18-5200

  • Soft-tissue surgical hook, reusable

BOSS Instruments - 00888515035478

Single Prong Micro Hook, sharp, 2mm, 5 5/8"
BOSS INSTRUMENTS, LTD., INC.
18-5198
In Commercial Distribution

  • 00888515035478 ()
18-5198

  • Soft-tissue surgical hook, reusable

BOSS Instruments - 00888515028074

Farr Retractor, #1, 5/8" prong, 5 1/2"
BOSS INSTRUMENTS, LTD., INC.
18-3170
In Commercial Distribution

  • 00888515028074 ()
18-3170

  • Self-retaining surgical retractor, reusable

Surgical Direct - B382SD917050120

5 inch Baby-Allis Tissue Forceps, 4 x 5 Teeth
Surgical Direct, Inc.
SD91705012
In Commercial Distribution

  • B382SD917050120 ()
SD91705012

  • Dressing/utility forceps, scissors-like, reusable

Surgical Direct - B382SD9034781030

5 5/8" Reynolds Dissecting Scissor, Slightly Curved, Blunt
Surgical Direct, Inc.
SD903478103
In Commercial Distribution

  • B382SD9034781030 ()
SD903478103

  • General-purpose surgical scissors, single-use

Novel - 00811801035746

5 MM TRIAL, 14 X 16 MM, 5 DEGREE
ALPHATEC SPINE, INC.
CI-10317-20-05
In Commercial Distribution

  • 00811801035746 ()


  • Spinal implant trial

Novel - 00811801034978

CERVICAL TRIAL, 5 HEIGHT, 14 WIDTH, 12 DEPTH, 5°
ALPHATEC SPINE, INC.
CI-10169-005
In Commercial Distribution

  • 00811801034978 ()

  • Height: 5 Millimeter
  • Angle: 5 degree
  • Depth: 12 Millimeter
  • Width: 14 Millimeter


  • Spinal implant trial

Novel - 00811801034466

5 MM TRIAL, 12 X 14 MM, 5 DEGREE
ALPHATEC SPINE, INC.
CI-10317-10-05
In Commercial Distribution

  • 00811801034466 ()


  • Spinal implant trial

gSource - 00840314229199

Hoke Osteotome 5 1/4" cvd 5/8" (16mm)
GSOURCE LLC
gS 52.6066
In Commercial Distribution

  • 00840314229199 ()
gS 52.6066

  • Orthopaedic osteotome

gSource - 00840314229168

Hoke Osteotome 5 1/4" cvd 5/16" (8mm)
GSOURCE LLC
gS 52.6058
In Commercial Distribution

  • 00840314229168 ()
gS 52.6058

  • Orthopaedic osteotome

gSource - 00840314229113

Hoke Osteotome 5 1/4" str 5/8" (16mm)
GSOURCE LLC
gS 52.6030
In Commercial Distribution

  • 00840314229113 ()
gS 52.6030

  • Orthopaedic osteotome

gSource - 00840314229083

Hoke Osteotome 5 1/4" str 5/16" (8mm)
GSOURCE LLC
gS 52.6000
In Commercial Distribution

  • 00840314229083 ()
gS 52.6000

  • Orthopaedic osteotome

Life Instruments - M9307121050010

Custom 12" Curette, #5/0 Str, w/5" Handle
Life Instrument Corporation
712-1050-0-1
In Commercial Distribution

  • M9307121050010 ()


  • Bone curette, reusable

Life Instruments - M93072011580C0

Custom Cobb Elevator 5/8" (5 3/4" handle)
Life Instrument Corporation
720-1158-0C
In Commercial Distribution

  • M93072011580C0 ()


  • Bone lever/elevator, reusable

Patient-Fitted TMJ Reconstructive Prosthesis System - 07613327626681

2.0 x 5 mm Self-Tapping Bone Screw, 5 Pack
TMJ Solutions, Inc.
65-2005
In Commercial Distribution



  • Total temporomandibular joint prosthesis

Bioplate® - M384SCE80505US1

Emergency Screw - Ø1.4 mm x 5 mm [5 PK]
Bioplate, Inc.
SCE8-05-05[US]
In Commercial Distribution

  • M384SCE80505US1 ()
  • M384SCE80505US0 ()

  • Length: 5 Millimeter
SCE8-05-05[US]

  • Craniofacial bone screw, non-bioabsorbable

Bioplate® - M384815742US1

Self-Drilling Screw - Low-Profile - Ø1.5mm x 5 mm [5 PK]
Bioplate, Inc.
81-5742[US]
In Commercial Distribution

  • M384815742US1 ()
  • M384815742US0 ()

  • Length: 5 Millimeter
81-5742[US]

  • Craniofacial bone screw, non-bioabsorbable

Bioplate® - M3848157421

Self-Drilling Screw - Low-Profile - Ø1.5mm x 5 mm [5 PK]
Bioplate, Inc.
81-5742
In Commercial Distribution

  • M3848157421 ()
  • M3848157420 ()

  • Length: 5 Millimeter
81-5742

  • Craniofacial bone screw, non-bioabsorbable

Bioplate® - M384SCE805051

Emergency Screw - Ø1.4 mm x 5 mm [5 PK]
Bioplate, Inc.
SCE8-03-05
In Commercial Distribution

  • M384SCE805051 ()
  • M384SCE805050 ()

  • Length: 5 Millimeter
  • Length: 3 Millimeter
SCE8-05-05

  • Craniofacial bone screw, non-bioabsorbable
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