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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K-Files, #15 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
DKF21/15
Not in Commercial Distribution

  • H834DKF21151 ()
  • 10381780485162 ()
  • 00381780485165 ()
DKF21/15

  • Manual endodontic file/rasp, single-use
Hedstrom Files, #15 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
DHF25/15
Not in Commercial Distribution

  • H834DHF25151 ()
  • 10381780485056 ()
  • 00381780485059 ()
DHF25/15

  • Manual endodontic file/rasp, single-use
Hedstrom Files, #15 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
DHF21/15
Not in Commercial Distribution

  • H834DHF21151 ()
  • 10381780484981 ()
  • 00381780484984 ()
DHF21/15

  • Manual endodontic file/rasp, single-use
Reamers, #15 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
DR25/15
Not in Commercial Distribution

  • H834DR25151 ()
  • 10381780485643 ()
  • 00381780485646 ()
DR25/15

  • Manual endodontic file/rasp, single-use
Reamers, #15 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
DR21/15
Not in Commercial Distribution

  • H834DR21151 ()
  • 10381780485582 ()
  • 00381780485585 ()
DR21/15

  • Manual endodontic file/rasp, single-use
K-Files, #15 31mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
DKF31/15
Not in Commercial Distribution

  • H834DKF31151 ()
  • 10381780485469 ()
  • 00381780485462 ()
DKF31/15

  • Manual endodontic file/rasp, single-use
DRIVER RATCHET F/ ABUT. EXTRA SHORT
Sin Sistema de Implante Nacional S/A
CDAC 15
In Commercial Distribution

  • 07899995266972 ()
CDAC 15

  • Surgical screwdriver, reusable
DRIVER RATCHET HEX.1.2MM EXTRA SHORT
Sin Sistema de Implante Nacional S/A
CDHC 15
In Commercial Distribution

  • 07899995265906 ()
CDHC 15

  • Surgical screwdriver, reusable
DRIVER RATCHET SQUA. 1.3MM EXTRA SHORT
Sin Sistema de Implante Nacional S/A
CQTM 15
In Commercial Distribution

  • 07899995267542 ()
CQTM 15

  • Surgical screwdriver, reusable
Implant
KEYSTONE DENTAL, INC.
BBBT 15
Not in Commercial Distribution

  • D768BBBT150 ()

  • Outer Diameter 3.25-6.0mm
BBBT 15

  • Screw endosteal dental implant, two-piece
Implant
KEYSTONE DENTAL, INC.
BBBS 15
Not in Commercial Distribution

  • D768BBBS150 ()

  • Outer Diameter 3.25-6.0mm
BBBS 15

  • Screw endosteal dental implant, two-piece
Implant
KEYSTONE DENTAL, INC.
BAT 15
Not in Commercial Distribution

  • D768BAT150 ()

  • Outer Diameter 3.25-6.0mm
BAT 15

  • Screw endosteal dental implant, two-piece
Implant
KEYSTONE DENTAL, INC.
BA 15
Not in Commercial Distribution

  • D768BA150 ()

  • Outer Diameter 3.25-6.0mm
BA 15

  • Screw endosteal dental implant, two-piece
Implant
KEYSTONE DENTAL, INC.
IBT 15
Not in Commercial Distribution

  • D768IBT150 ()

  • Outer Diameter 3.25-6.0mm
IBT 15

  • Screw endosteal dental implant, two-piece
Implant
KEYSTONE DENTAL, INC.
IBS 15
Not in Commercial Distribution

  • D768IBS150 ()

  • Outer Diameter 3.25-6.0mm
IBS 15

  • Screw endosteal dental implant, two-piece
Implant
KEYSTONE DENTAL, INC.
IBN 15
Not in Commercial Distribution

  • D768IBN150 ()

  • Outer Diameter 3.25-6.0mm
IBN 15

  • Screw endosteal dental implant, two-piece
RING FIXATION FLIERINGA 15MM
Bausch & Lomb Incorporated
E4034 15
In Commercial Distribution

  • 00757770432905 ()
E4034 15

  • Flieringa ophthalmic ring
Implant pick-up
MEDENTiKA GmbH
T 15
In Commercial Distribution

  • 04251574829108 ()
  • EMKAT159 ()

  • compatible with DENTSPLY Implants / XiVE®* S
T 15

  • Dental implant suprastructure, temporary, preformed, reusable
HRA TRIAL SZ. 44/15
Smith & Nephew, Inc.
TRL-900-44/15
In Commercial Distribution

  • 00885556837474 ()
TRL-900-44/15

  • Humeral head prosthesis trial, reusable
HRA SHAPER SZ. 44/15
Smith & Nephew, Inc.
SHP-900-44/15
In Commercial Distribution

  • 00885556837313 ()
SHP-900-44/15

  • Bone cutter
FORCEP BIPOLAR COAPTATION
Bausch & Lomb Incorporated
S2050 15
In Commercial Distribution

  • 00757770402793 ()
S2050 15

  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Connection hose DIN, CO2, NIST-screwing to NIST-screwing, ISO color, 1.50 m long
DEHAS Medical Systems GmbH
DIN-CO2-NIST-NIST-1,5
In Commercial Distribution

  • 04251411701833 ()
DIN-CO2-NIST-NIST1,5

  • Carbon dioxide low pressure hose
Probe UNC 15 (1 thru 15 by 1mm)
PDT, INC.
R198 Probe UNC 15 (1 thru 15 by 1mm)
In Commercial Distribution

  • 00813677021229 ()
R198

  • Periodontal probe, reusable
15 mm x 29 mm, 15 degree Distractor
Integrity Implants Inc.
CMP-00537
In Commercial Distribution

  • 00810004727199 ()
CMP-00537

  • Orthopaedic surgical distractor, internal
Straight Connector 15 mm O.D. ; 15 mm O.D.
VBM Medizintechnik GmbH
60-50-005
In Commercial Distribution

  • 04250105604580 ()

  • 15 mm O.D. / 15 mm O.D.


  • Straight/elbow breathing circuit connector, reusable
BluEX-A (29 X 38 X 15 mm, 15°)
L&K BIOMED CO. ,LTD.
BA2938-1515S
In Commercial Distribution

  • 08809986466006 ()


  • Metallic spinal interbody fusion cage
Z-Link Lumbar Sizer 15 deg, 38mm x 15
Zavation LLC
180S-1538-15
In Commercial Distribution

  • 00842166177499 ()


  • Polymeric spinal interbody fusion cage
Z-Link Lumbar Sizer 15 deg, 33mm x 15
Zavation LLC
180S-1533-15
In Commercial Distribution

  • 00842166177444 ()


  • Polymeric spinal interbody fusion cage
ALIF TRIAL 15° 28 X 38 X 15
Corentec Co., Ltd
SI.C20.0515
In Commercial Distribution

  • 08800017285344 ()


  • Spinal implant trial
Pediatric Axiom Positioning Cushion 15 X 15, Purple
KI MOBILITY, LLC
PXP
In Commercial Distribution

  • 00840363363523 ()

  • 15 X 15, Purple
PXP1515PUR

  • Wheelchair seat cushion
Pediatric Axiom Positioning Cushion 15 X 15, Blue
KI MOBILITY, LLC
PXP
In Commercial Distribution

  • 00840363363516 ()

  • 15 X 15, Blue
PXP1515BLU

  • Wheelchair seat cushion
Pediatric Axiom Positioning Cushion 15 X 15, Black
KI MOBILITY, LLC
PXP
In Commercial Distribution

  • 00840363363509 ()

  • 15 X 15, Black
PXP1515BLK

  • Wheelchair seat cushion
Base Mold 15 x 15 x 5 mm
SAKURA FINETEK U.S.A., INC.
4162
In Commercial Distribution

  • 00615233078094 ()
4162

  • Tissue embedding mould IVD, reusable
GLIDE CHAIN ELASTIC LONG ROYAL BLUE 15' 15'
Ortho Arch Company Inc
300-407
In Commercial Distribution

  • D90930040700 ()
300-407

  • Orthodontic inter-bracket elastic chain
LK15cm-15ga CertusLK Ablation Probe, 15 cm, 15 ga
NEUWAVE MEDICAL, INC.
2.45 GHz Ablation System
Not in Commercial Distribution

  • 00853719006067 ()
LK15cm - 15ga

  • Microwave ablation system probe, non-powered
PR15cm-15ga CertusPR Ablation Probe, 15 cm, 15 ga
NEUWAVE MEDICAL, INC.
2.45 GHz Ablation System
Not in Commercial Distribution

  • 00853719006029 ()
PR15cm - 15ga

  • Microwave ablation system probe, non-powered
IMS STERILIZATION WRAP 15 X 15 100 SHEET
HU-FRIEDY MFG. CO., LLC
IMS-1211H
In Commercial Distribution

  • 10889950002763 ()
  • 10889950075040 ()
IMS-1211H

  • Sterilization packaging, single-use
Superelastic staple 15 x 15 x 15mm sterile
NEOSTEO
A5151515
In Commercial Distribution

  • 03701173703756 ()

  • Inter-Leg Distance 15mm, Leg Lengths 15x15mm
A5151515

  • Orthopaedic bone staple, non-adjustable
CONN 22/15 X 22/15 7020 SERIES
HANS RUDOLPH, INC.
7020
Not in Commercial Distribution

  • 00817136022277 ()
200274

  • Straight/elbow breathing circuit connector, reusable
Finocchietto Rib Spreader 15 x 15 x 75mm
Surgical Direct, Inc.
SD918092080
In Commercial Distribution

  • B382SD9180920800 ()
SD918092080

  • Self-retaining surgical retractor, reusable
No Description
Biomet Orthopedics, LLC
9032-08-015
In Commercial Distribution

  • 00887868064326 ()

  • +15
903208015

  • Bone nail end-cap
No Description
Biomet Orthopedics, LLC
8142-35-115
Not in Commercial Distribution

  • 00887868037931 ()

  • +15
814235115

  • Orthopaedic bone screw (non-sliding)
No Description
Biomet Orthopedics, LLC
8142-35-015
Not in Commercial Distribution

  • 00887868037894 ()

  • +15
814235015

  • Orthopaedic bone screw (non-sliding)
No Description
Biomet Orthopedics, LLC
909871
In Commercial Distribution

  • 00887868569036 ()

  • 15°
909871

  • Orthopaedic osteotome
No Description
Biomet Orthopedics, LLC
904804
In Commercial Distribution

  • 00887868567667 ()

  • 15°
904804

  • Bone file/rasp, manual, reusable
No Description
Biomet Orthopedics, LLC
904800
In Commercial Distribution

  • 00887868567643 ()

  • 15°
904800

  • Bone file/rasp, manual, reusable
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
SIGNUS Medizintechnik GmbH
Curette, rectangular
In Commercial Distribution

  • 04047844059814 ()

  • 15°
SK-0101

  • Orthopaedic surgical procedure kit, non-medicated, reusable
broach
implantcast GmbH
80049015
In Commercial Distribution

  • 04048844196608 ()

  • 15


  • Orthopaedic broach
15° Modular Trial Caddy
Seaspine Orthopedics Corporation
86-9922
In Commercial Distribution

  • 10889981144982 ()

  • 15°
86-9922

  • Instrument tray, reusable
Angled Back Down Curette, 15"
Seaspine Orthopedics Corporation
93-4147
In Commercial Distribution

  • 10889981089832 ()

  • 15"
93-4147

  • Bone curette, reusable
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