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, Level 4, knit v-neck, ties at waist, grips at neck, patented Size 2XL
Lac-Mac Limited
005XH-2XL
In Commercial Distribution

  • 00627755056153 ()

  • Height: 53.5 Inch
  • Width: 31.5 Inch
005XH-2XL

  • Surgical gown, reusable
Surgical Gown, Level 4, knit v-neck, ties at waist, grips at neck, patented Size XL
Lac-Mac Limited
005XFAN-XL
In Commercial Distribution

  • 00627755055972 ()

  • Height: 56.25 Inch
005XFAN-XL

  • Surgical gown, reusable
Surgical Gown, Level 4, knit v-neck, ties at waist, grips at neck, patented Size XL
Lac-Mac Limited
005XH-XL
In Commercial Distribution

  • 00627755055156 ()

  • Height: 52.5 Inch
  • Width: 29 Inch
005XH-XL

  • Surgical gown, reusable
Surgical Gown, Level 4, knit v-neck, ties at waist, grips at neck, patented Size L
Lac-Mac Limited
005XFAN-L
In Commercial Distribution

  • 00627755054975 ()

  • Height: 54.25 Inch
005XFAN-L

  • Surgical gown, reusable
Surgical Gown, Level 4, knit v-neck, ties at waist, grips at neck, patented Size L
Lac-Mac Limited
005XH-L
In Commercial Distribution

  • 00627755054159 ()

  • Height: 51.5 Inch
  • Width: 27.5 Inch
005XH-L

  • Surgical gown, reusable
Surgical Gown, Level 4, knit v-neck, ties at waist, grips at neck, patented Size M
Lac-Mac Limited
005XFAN-M
In Commercial Distribution

  • 00627755053978 ()

  • Height: 54.25 Inch
005XFAN-M

  • Surgical gown, reusable
Surgical Gown, Level 4, knit v-neck, ties at waist, grips at neck, patented Size S
Lac-Mac Limited
005XH-S
In Commercial Distribution

  • 00627755052155 ()

  • Height: 49.5 Inch
  • Width: 23.5 Inch
005XH-S

  • Surgical gown, reusable
Surgical Gown, Level 4, knit v-neck, ties at waist, grips at neck, patented Size XS
Lac-Mac Limited
005XH-XS
In Commercial Distribution

  • 00627755051158 ()

  • Width: 21.5 Inch
  • Height: 48.5 Inch
005XH-XS

  • Surgical gown, reusable
Surgical Gown, Level 4, knit v-neck, ties at waist, grips at neck, patented Size M
Lac-Mac Limited
005XH-M
In Commercial Distribution

  • 00627755053152 ()

  • Height: 50.5 Inch
  • Width: 25.5 Inch
005XH-M

  • Surgical gown, reusable
18in Angled Arm 8x10in At 45Deg
THOMPSON SURGICAL INSTRUMENTS, INC.
10044118N
In Commercial Distribution

  • 00851099006523 ()


  • Surgical retraction system, reusable
HT, ITC/ITE AT BE HIT
Oticon A/S
106-31-290-10
In Commercial Distribution

  • 05707131130822 ()


  • Air-conduction hearing aid, in-the-ear
Dual Sided Rasp, Angled at 50mm
Seaspine Orthopedics Corporation
SR-0529
In Commercial Distribution

  • 10889981255640 ()
SR-0529

  • Bone file/rasp, manual, reusable
Speedlock Grasping Forceps, 5mm, serrated, at
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8512-25-26
In Commercial Distribution

  • 00848657003155 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
ScanPost AT OS 4.5/5.0 L
SIRONA Dental Systems GmbH
6431063
In Commercial Distribution

  • E27664310630 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
ScanPost AT OS 3.5/4.0 L
SIRONA Dental Systems GmbH
6431055
In Commercial Distribution

  • E27664310550 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
Cerec Guide Drill Key Set AT
SIRONA Dental Systems GmbH
6373950
In Commercial Distribution

  • E27663739502 ()


  • CAD/CAM software
TiBase AT OS 4.5/5.0 L
SIRONA Dental Systems GmbH
62 82 540
In Commercial Distribution

  • E27662825400 ()
62 82 540

  • Dental implant suprastructure, permanent, preformed
TiBase AT OS 3.5/4.0 L
SIRONA Dental Systems GmbH
62 82 532
In Commercial Distribution

  • E27662825320 ()
62 82 532

  • Dental implant suprastructure, permanent, preformed
Angled Chisel - 15 degrees at 70mm
ALPHATEC SPINE, INC.
CI-10906
In Commercial Distribution

  • 00840180507193 ()


  • Orthopaedic chisel
TiBase AT EV 5.4 GH3 L
SIRONA Dental Systems GmbH
6832666
In Commercial Distribution

  • E27668326660 ()
6832666

  • Dental implant suprastructure, permanent, preformed
TiBase AT EV 4.8 GH3 L
SIRONA Dental Systems GmbH
6832658
In Commercial Distribution

  • E27668326580 ()
6832658

  • Dental implant suprastructure, permanent, preformed
TiBase AT EV 3.6 GH3 S
SIRONA Dental Systems GmbH
6832633
In Commercial Distribution

  • E27668326330 ()
6832633

  • Dental implant suprastructure, permanent, preformed
TiBase AT EV 3.0 GH3 S
SIRONA Dental Systems GmbH
6832625
In Commercial Distribution

  • E27668326250 ()
6832625

  • Dental implant suprastructure, permanent, preformed
TiBase AT EV 5.4 GH2 L
SIRONA Dental Systems GmbH
6832617
In Commercial Distribution

  • E27668326170 ()
6832617

  • Dental implant suprastructure, permanent, preformed
TiBase AT EV 4.8 GH2 L
SIRONA Dental Systems GmbH
6832609
In Commercial Distribution

  • E27668326090 ()
6832609

  • Dental implant suprastructure, permanent, preformed
TiBase AT EV 3.6 GH2 S
SIRONA Dental Systems GmbH
6832583
In Commercial Distribution

  • E27668325830 ()
6832583

  • Dental implant suprastructure, permanent, preformed
TiBase AT EV 3.0 GH2 S
SIRONA Dental Systems GmbH
6832575
In Commercial Distribution

  • E27668325750 ()
6832575

  • Dental implant suprastructure, permanent, preformed
TiBase AT EV 5.4 GH1 L
SIRONA Dental Systems GmbH
6586346
In Commercial Distribution

  • E27665863462 ()
6586346

  • Dental implant suprastructure, permanent, preformed
TiBase AT EV 4.8 GH1 L
SIRONA Dental Systems GmbH
6586338
In Commercial Distribution

  • E27665863382 ()
6586338

  • Dental implant suprastructure, permanent, preformed
TiBase AT EV 4.2 GH1 L
SIRONA Dental Systems GmbH
6586320
In Commercial Distribution

  • E27665863202 ()
6586320

  • Dental implant suprastructure, permanent, preformed
TiBase AT EV 3.6 GH1 S
SIRONA Dental Systems GmbH
6586312
In Commercial Distribution

  • E27665863122 ()
6586312

  • Dental implant suprastructure, permanent, preformed
Abutment Screw AT OS 4.5/5.0
SIRONA Dental Systems GmbH
64 60 443
In Commercial Distribution

  • E27664604432 ()
  • E27662819140 ()
64 60 443

  • Dental implant suprastructure, permanent, preformed
Abutment Screw AT OS 3.5/4.0
SIRONA Dental Systems GmbH
64 60 344
In Commercial Distribution

  • E27664603442 ()
  • E27662819060 ()
64 60 344

  • Dental implant suprastructure, permanent, preformed
AI AT Compression Screws Tray Assembly
Acumed LLC
AI-1520
In Commercial Distribution

  • 10806378054716 ()


  • Orthopaedic implant/instrument assembling device
IB3D TB trial 15mm at 6°
MEDICREA INTERNATIONAL
A99181115
Not in Commercial Distribution

  • 03613720275770 ()
A99181115

  • Orthopaedic surgical procedure kit, non-medicated, reusable
IB3D TB trial 14mm at 6°
MEDICREA INTERNATIONAL
A99181114
Not in Commercial Distribution

  • 03613720275763 ()
A99181114

  • Orthopaedic surgical procedure kit, non-medicated, reusable
IB3D TB trial 13mm at 6°
MEDICREA INTERNATIONAL
A99181113
Not in Commercial Distribution

  • 03613720275756 ()
A99181113

  • Orthopaedic surgical procedure kit, non-medicated, reusable
IB3D TB trial 12mm at 6°
MEDICREA INTERNATIONAL
A99181112
Not in Commercial Distribution

  • 03613720275749 ()
A99181112

  • Orthopaedic surgical procedure kit, non-medicated, reusable
IB3D TB trial 11mm at 6°
MEDICREA INTERNATIONAL
A99181111
Not in Commercial Distribution

  • 03613720275732 ()
A99181111

  • Orthopaedic surgical procedure kit, non-medicated, reusable
IB3D TB trial 10mm at 6°
MEDICREA INTERNATIONAL
A99181110
Not in Commercial Distribution

  • 03613720275725 ()


  • Spinal implant trial
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