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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Crestone One Piece Implant ø3.5 L11.5mm
NOGA MEDICAL PRODUCTS LTD
B
In Commercial Distribution

  • 07290118140665 ()
IC1-35011

  • Dental implant system
Crestone One Piece Implant ø3.50 L10mm
NOGA MEDICAL PRODUCTS LTD
B
In Commercial Distribution

  • 07290118140658 ()
IC1-35010

  • Dental implant system
Crestone One Piece Implant ø3 L16mm
NOGA MEDICAL PRODUCTS LTD
B
In Commercial Distribution

  • 07290118140641 ()
IC1-30016

  • Dental implant system
Crestone One Piece Implant ø3 L13mm
NOGA MEDICAL PRODUCTS LTD
B
In Commercial Distribution

  • 07290118140634 ()
IC1-30013

  • Dental implant system
Crestone One Piece Implant ø3 L11.50mm
NOGA MEDICAL PRODUCTS LTD
B
In Commercial Distribution

  • 07290118140627 ()
IC1-30011

  • Dental implant system
Crestone One Piece Implant ø3 L10mm
NOGA MEDICAL PRODUCTS LTD
B
In Commercial Distribution

  • 07290118140610 ()
IC1-30010

  • Dental implant system
BIO | One Stage Implant Driver Long
BLUE SKY BIO LLC
DT0018
In Commercial Distribution

  • 00810060221419 ()


  • Surgical torque wrench adaptor
BIO | One Stage Implant Driver Short
BLUE SKY BIO LLC
DT0014
In Commercial Distribution

  • 00810060221402 ()


  • Surgical torque wrench adaptor
BIO | One Stage Digital Scan Body
BLUE SKY BIO LLC
MOD5500
In Commercial Distribution

  • 00810060224939 ()


  • Dental implant analog
Pad leg section one part light
Baxter Medical Systems GmbH + Co. KG
1611308
Not in Commercial Distribution

  • 00887761969841 ()


  • Operating table patient pressure distribution pad, reusable
Leg section one part H V
Baxter Medical Systems GmbH + Co. KG
1850959
In Commercial Distribution

  • 00887761970366 ()


  • Operating table orthopaedic extension, non-powered
Pad leg section one part short
Baxter Medical Systems GmbH + Co. KG
1570940
Not in Commercial Distribution

  • 00887761969919 ()


  • Operating table patient pressure distribution pad, reusable
Pad TTS Carbon one part B
Baxter Medical Systems GmbH + Co. KG
1873466
Not in Commercial Distribution

  • 00887761969421 ()


  • Operating table mattress, basic
Pad TTS Carbon one part G
Baxter Medical Systems GmbH + Co. KG
2080466
In Commercial Distribution

  • 00887761968899 ()


  • Operating table orthopaedic extension, non-powered
Leg section one part M EU
Baxter Medical Systems GmbH + Co. KG
2066984
Not in Commercial Distribution

  • 00887761967786 ()


  • Operating table orthopaedic extension, non-powered
DRIVER 9010009005 ONE SIDE SWIZZLE STICK
MEDTRONIC SOFAMOR DANEK, INC.
9010009005
In Commercial Distribution

  • 00763000218256 ()


  • Orthopaedic implant driver
TAUT SYSTEM ONE TRIFECTA BALLOON 5FRX75
TELEFLEX INCORPORATED
IPN007865
In Commercial Distribution

  • 24026704418910 ()

  • Length: 86.5 Centimeter
50640

  • Laparoscopic access cannula, single-use
Reflex One, Skin Stapler, 35 wide
Conmed Corporation
8535
In Commercial Distribution

  • 10653405036951 ()
  • 20653405036958 ()
  • 00653405036954 ()
8535

  • Skin stapler/staple, non-bioabsorbable
Reflex One, Skin Stapler, 35 regular
Conmed Corporation
8035
In Commercial Distribution

  • 10653405036920 ()
  • 20653405036927 ()
  • 00653405036923 ()
8035

  • Skin stapler/staple, non-bioabsorbable
Reflex One, Skin Stapler, 35 regular
Conmed Corporation
3036R
In Commercial Distribution

  • 10653405050599 ()
  • 20653405050596 ()
  • 00653405050592 ()
3036R

  • Skin stapler/staple, non-bioabsorbable
Reflex One, Skin Stapler, 35 wide
Conmed Corporation
3036
In Commercial Distribution

  • 10653405048381 ()
  • 20653405048388 ()
  • 00653405048384 ()
3036

  • Skin stapler/staple, non-bioabsorbable
VM 9 ONE COLOR KIT A2
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
BV9OCKA2V4
In Commercial Distribution

  • J017BV9OCKA2V40 ()
BV9OCKA2V4

  • Dental appliance fabrication material, ceramic
VM 9 One Color Kit 2M2
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
BV9OCK2M2V5
In Commercial Distribution

  • J017BV9OCK2M2V50 ()
BV9OCK2M2V5

  • Dental appliance fabrication material, ceramic
Cervical Tissue Retractor, one blunt prong
Avalign Technologies, Inc.
VM84-2231
In Commercial Distribution

  • 00190776015275 ()

  • Length: 5.125 Inch


  • Self-retaining surgical retractor, reusable
PINNACLE ONE PC REVISION PERIPHERAL DRILL
DEPUY ORTHOPAEDICS, INC.
2274-81-000
In Commercial Distribution

  • 10603295109433 ()
227481000

  • Fluted surgical drill bit, reusable
Rampart One Trial, 14mm, M, 12°
SPINEOLOGY INC.
49-02-01-16
In Commercial Distribution

  • M7404902016 ()

  • Medium Footprint
  • 12° Lordosis
  • Height: 14 Millimeter
490-2016

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 12mm, M, 12°
SPINEOLOGY INC.
49-02-01-15
In Commercial Distribution

  • M7404902015 ()

  • Height: 12 Millimeter
  • 12° Lordosis
  • Medium Footprint
490-2015

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 16mm, M, 8°
SPINEOLOGY INC.
49-02-01-13
In Commercial Distribution

  • M7404902013 ()

  • Medium Footprint
  • 8° Lordosis
  • Height: 16 Millimeter
490-2013

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 14mm, M, 8°
SPINEOLOGY INC.
49-02-01-12
In Commercial Distribution

  • M7404902012 ()

  • Height: 14 Millimeter
  • 8° Lordosis
  • Medium Footprint
490-2012

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 12mm, M, 8°
SPINEOLOGY INC.
49-02-01-11
In Commercial Distribution

  • M7404902011 ()

  • Medium Footprint
  • 8° Lordosis
  • Height: 12 Millimeter
490-2011

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 10.5mm, M, 8°
SPINEOLOGY INC.
49-02-01-10
In Commercial Distribution

  • M7404902010 ()

  • Height: 10.5 Millimeter
  • 8° Lordosis
  • Medium Footprint
490-2010

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 14mm, S, 12°
SPINEOLOGY INC.
49-02-01-7
In Commercial Distribution

  • M7404902007 ()

  • Height: 14 Millimeter
  • 12° Lordosis
  • Small Footprint
490-2007

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 12mm, S, 12°
SPINEOLOGY INC.
49-02-01-6
In Commercial Distribution

  • M7404902006 ()

  • Small Footprint
  • 12° Lordosis
  • Height: 12 Millimeter
490-2006

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 14mm, S, 8°
SPINEOLOGY INC.
49-02-01-3
In Commercial Distribution

  • M7404902003 ()

  • Small Footprint
  • 8° Lordosis
  • Height: 14 Millimeter
490-2003

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 12mm, S, 8°
SPINEOLOGY INC.
49-02-01-2
In Commercial Distribution

  • M7404902002 ()

  • Height: 12 Millimeter
  • 8° Lordosis
  • Small Footprint
490-2002

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 10.5mm, S, 8°
SPINEOLOGY INC.
49-02-01-1
In Commercial Distribution

  • M7404902001 ()

  • Small Footprint
  • 8° Lordosis
  • Height: 10.5 Millimeter
490-2001

  • Polymeric spinal fusion cage, sterile
Rampart One 28 cm Trial Inserter
SPINEOLOGY INC.
102-53-01
In Commercial Distribution

  • M7401021292 ()

  • Length: 28 Centimeter
102-1292

  • Surgical implant/trial-implant/sizer holder, reusable
ONE THIRD TUBULAR PLATE - 8 HOLE
Smith & Nephew, Inc.
2813008
In Commercial Distribution

  • 00885556838556 ()
2813008

  • Orthopaedic fixation plate, non-bioabsorbable
ONE THIRD TUBULAR PLATE - 6 HOLE
Smith & Nephew, Inc.
2813006
In Commercial Distribution

  • 00885556838549 ()
2813006

  • Orthopaedic fixation plate, non-bioabsorbable
ONE THIRD TUBULAR PLATE - 4 HOLE
Smith & Nephew, Inc.
2813004
In Commercial Distribution

  • 00885556838532 ()
2813004

  • Orthopaedic fixation plate, non-bioabsorbable
LMP SYSTEM PROXIMAL BROACH. ONE SIZE
Smith & Nephew, Inc.
LMP-PST
In Commercial Distribution

  • 00885556834626 ()
LMP-PST

  • Orthopaedic broach
LMP SYSTEM DISTAL BROACH. ONE SIZE
Smith & Nephew, Inc.
LMP-DST
In Commercial Distribution

  • 00885556834602 ()
LMP-DST

  • Orthopaedic broach
ONE PIECE DESIGN C-ARM DRP, 1-EACH
Microtek Medical LLC
1
In Commercial Distribution

  • 30748426005513 ()
  • 00748426005512 ()
  • 50748426005517 ()


  • Instrument/equipment drape, single-use, sterile
All In One Stylet, Extra-Short, Sterile
SPINEOLOGY INC.
67-23-10-5
In Commercial Distribution

  • M7406700076 ()
670-0076

  • Orthopaedic intraoperative positioning pin, single-use
All In One Stylet, Short, Non-Sterile
SPINEOLOGY INC.
67-23-10-2
In Commercial Distribution

  • M7406700071 ()
670-0071

  • Surgical drill guide, reusable
All In One Stylet, Long, Non-Sterile
SPINEOLOGY INC.
67-23-10-1
In Commercial Distribution

  • M7406700070 ()
670-0070

  • Surgical drill guide, reusable
Mesh Gauze One Plus 17 PLY
DEROYAL INDUSTRIES, INC.
10-5510
In Commercial Distribution

  • 50749756038718 ()
  • 00749756038713 ()
10-5510

  • Wound-nonadherent dressing, permeable, non-antimicrobial
Mesh Gauze One Plus 6 PLY
DEROYAL INDUSTRIES, INC.
10-5500
In Commercial Distribution

  • 50749756038572 ()
  • 00749756038577 ()
  • 10749756038574 ()
10-5500

  • Wound-nonadherent dressing, permeable, non-antimicrobial
Rampart One Trial, 18mm, M, 12°
SPINEOLOGY INC.
49-02-01-34
In Commercial Distribution

  • M7404902034 ()

  • 12° Lordosis
  • Medium Footprint
  • Height: 18 Millimeter
490-2034

  • Polymeric spinal fusion cage, sterile
Rampart One Trial, 18mm, M, 20°
SPINEOLOGY INC.
49-02-01-33
In Commercial Distribution

  • M7404902033 ()

  • 20° Lordosis
  • Medium Footprint
  • Height: 18 Millimeter
490-2033

  • Polymeric spinal fusion cage, sterile
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