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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Rampart One Guide, 14mm
SPINEOLOGY INC.
49-12-12
In Commercial Distribution

  • M7404900003 ()

  • Height: 14 Millimeter
490-0003

  • Polymeric spinal fusion cage, sterile
Rampart One Guide, 12mm
SPINEOLOGY INC.
49-12-11
In Commercial Distribution

  • M7404900002 ()

  • Height: 12 Millimeter
490-0002

  • Polymeric spinal fusion cage, sterile
Rampart One Guide, 10.5mm
SPINEOLOGY INC.
49-12-10
In Commercial Distribution

  • M7404900001 ()

  • Height: 10.5 Millimeter
490-0001

  • Polymeric spinal fusion cage, sterile
T25 SCREWDRIVER ONE PIECE
Smith & Nephew, Inc.
E0017128-2
In Commercial Distribution

  • 00885556794487 ()
E0017128-2

  • Surgical screwdriver, reusable
T25 SCREWDRIVER ONE PIECE
Smith & Nephew, Inc.
E0017884-2
In Commercial Distribution

  • 00885556889695 ()
E0017884-2

  • Surgical screwdriver, reusable
Square Driver One Piece
NOGA MEDICAL PRODUCTS LTD
A
In Commercial Distribution

  • 07290118145400 ()
TK1-0011

  • Dental implant system
TL+ ONE HOLE POST
ORTHOFIX SRL
1
In Commercial Distribution

  • 18033509856754 ()
54-11600

  • External orthopaedic fixation system, single-use
Universal Stage One Handpiece
IPG Medical Corporation
MD2300F-001754
In Commercial Distribution

  • 00810071230547 ()


  • Musculoskeletal/physical therapy laser, professional
Universal Strap - One Piece - One Closure - 108" Length X 6" Width
SOULE CO., THE
RUSOPC12
In Commercial Distribution

  • 00810082221480 ()
RUSOPC12

  • Freestanding patient positioner, single-use
Universal Strap - One Piece - One Closure - 96" Length X 6" Width
SOULE CO., THE
RUSOPC11
In Commercial Distribution

  • 00810082221473 ()
RUSOPC11

  • Freestanding patient positioner, single-use
Universal Strap - One Piece - One Closure - 76" Length X 6" Width
SOULE CO., THE
RUSOPC10
In Commercial Distribution

  • 00810082221466 ()
RUSOPC10

  • Freestanding patient positioner, single-use
Universal Strap - One Piece - One Closure - 108" Length X 4" Width
SOULE CO., THE
RUSOPC09
In Commercial Distribution

  • 00810082221459 ()
RUSOPC09

  • Freestanding patient positioner, single-use
Universal Strap - One Piece - One Closure - 76" Length X 4" Width
SOULE CO., THE
RUSOPC07
In Commercial Distribution

  • 00810082221435 ()
RUSOPC07

  • Freestanding patient positioner, single-use
Universal Strap - One Piece - One Closure - 108" Length X 3" Width
SOULE CO., THE
RUSOPC06
In Commercial Distribution

  • 00810082221428 ()
RUSOPC06

  • Freestanding patient positioner, single-use
Universal Strap - One Piece - One Closure - 96" Length X 3" Width
SOULE CO., THE
RUSOPC05
In Commercial Distribution

  • 00810082221411 ()
RUSOPC05

  • Freestanding patient positioner, single-use
Universal Strap - One Piece - One Closure - 76" Length X 3" Width
SOULE CO., THE
RUSOPC04
In Commercial Distribution

  • 00810082221404 ()
RUSOPC04

  • Freestanding patient positioner, single-use
Universal Strap - One Piece - One Closure - 76" Length X 2" Width
SOULE CO., THE
RUSOPC01
In Commercial Distribution

  • 00810082221374 ()
RUSOPC01

  • Freestanding patient positioner, single-use
Contents: One 5mm Pilot Guide and one 10/12mm Pilot Guide
Coopersurgical, Inc.
PG-5/10
In Commercial Distribution

  • 20888937002991 ()
  • 60888937002999 ()


  • Laparoscopic wound closure thread
One 3.38 FL OZ (100 mL) bottle with one lice comb.
MENTHOLATUM COMPANY, THE
1123
In Commercial Distribution

  • 00310742011234 ()


  • Lice treatment solution, synthetic
  • Lice comb, manual
Gauze scissors, one serrated blade/one large ring, stainless steel, 8"
BV Medical
80-163-000
In Commercial Distribution

  • 00845821010353 ()


  • General-purpose surgical scissors, reusable
Toshiba Aquilion One CT, Canon Cartesion CT one piece cradle top
MEDTEC, INC.
MTIL6521
In Commercial Distribution

  • 00841439106150 ()
MTIL6521

  • Indexed-immobilization patient positioning system
9 inch Alligator Rongeur, with One Flat Handle, One Ring Handle
Surgical Direct, Inc.
SD92281202
In Commercial Distribution

  • B382SD922812020 ()
SD92281202

  • Orthopaedic joint/limb rongeur
7 inch Alligator Rongeur, with One Flat Handle, One Ring Handle
Surgical Direct, Inc.
SD92281201
In Commercial Distribution

  • B382SD922812010 ()
SD92281201

  • Orthopaedic joint/limb rongeur
5 inch Alligator Rongeur, with One Flat Handle, One Ring Handle
Surgical Direct, Inc.
SD92281200
In Commercial Distribution

  • B382SD922812000 ()
SD92281200

  • Orthopaedic joint/limb rongeur
Monitor with one blood parameter module and one H/S Probe.
Terumo Cardiovascular Systems Corporation
550AHCT
In Commercial Distribution

  • 00886799001790 ()
550AHCT

  • Extracorporeal blood gas/pH monitor
Monitor with one blood parameter module and one H/S Probe.
Terumo Cardiovascular Systems Corporation
500AHCT
In Commercial Distribution

  • 00886799001622 ()
500AHCT

  • Extracorporeal blood gas/pH monitor
Contains one (1) 500 gram powder (Pink), one (1) 500 milliliter liquid, and one (1) 105 milliliter sealer
Dentsply International Inc.
Soft Denture Liner 500 G Kit Pink
Not in Commercial Distribution

  • D001N8125000 ()
N812500

  • Dental appliance fabrication material, resin
Sample pack containing one of each: 1) One by Poise Extra Coverage Liner,2) One by Poise Heavy Pad, 3) One by Poise Reg Pad
KIMBERLY-CLARK GLOBAL SALES, INC.
Pad
In Commercial Distribution

  • 00036000670011 ()


  • Menstrual pad, unscented
Premium Condom samplers 96 ct. List of condoms in the bag: One Flavor Waves, Lifestyles Tuxedo (A6200C), One Vanish, Crown (LC21C), One Flex, L.A.Confidential (Love Triangle) Studded (CW1000LAC), Trojan Enz, One Ultra Feel, Lifestyles SKYN Original (A7800C), My One 51F, My One 53F, My One 53 G,
GLOBAL PROTECTION CORP.
BSC01096
In Commercial Distribution

  • 80726893112878 ()
  • 00726893112872 ()


  • Basic male condom, Hevea-latex
VG BREAST 3T 16CH TT GE750 FULL SET w GRD contains one patient support assembly, one box of 10 sterilized biopsy grids, one Lateral array coil left and right coil, one Medial array coil, one Interface box, one Coil Single loop left and right, and one medial plug.
Philips Medical Systems Nederland B.V.
989603217121
In Commercial Distribution

  • 00884838119833 ()


  • MRI system coil, radio-frequency
Sam Chest Seal Combo Pack Folded, One with Valve, One Withour Valve
BOUND TREE MEDICAL, LLC
1216-01106D
In Commercial Distribution

  • 00815277028301 ()
1216-01106D

  • First aid kit, non-medicated, single-use
3.2mm Draw Tight Suture Anchor with One Suture and One Suture Tape
PARCUS MEDICAL LLC
11150
In Commercial Distribution

  • M685111500 ()
11150

  • Tendon/ligament bone anchor, non-bioabsorbable
Attachment Cleaning Brushes (One 7 in Brush and One 12 in Brush)
Synthes GmbH
ACB
In Commercial Distribution

  • 00845384000211 ()
ACB

  • Surgical instrument/endoscope cleaning utensil, single-use
One spike to one male luer with 150cm tubing and roller clamp
ORIGEN BIOMEDICAL, INC.
150-S-M
Not in Commercial Distribution

  • 10816203020588 ()
  • 20816203020585 ()


  • Blood transfer set
One female luer to one male luer with 12cm DMSO resistant tubing
ORIGEN BIOMEDICAL, INC.
12-F-M
Not in Commercial Distribution

  • 10816203020557 ()
  • 20816203020554 ()


  • Blood transfer set
Davis Interlocking Sounds, One male, One Female, 10.75" OL, Set of Two
Avalign Technologies, Inc.
1-GU8100
In Commercial Distribution

  • 00190776384906 ()


  • Uterine sound, reusable
Cottle Hook Retractor, 14cm Left, double prong, one sharp,one ball tip
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
ASSI.AG40562
In Commercial Distribution

  • 00841645128052 ()


  • Hand-held surgical retractor, reusable
Cottle Hook Retractor, 14cm Right, double prong, one sharp,one ball tip
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
ASSI.AG40462
In Commercial Distribution

  • 00841645128014 ()


  • Hand-held surgical retractor, reusable
WaterPAP Pro (10 devices in one box. 10 boxes in one case)
WESTMED, INC.
WP-7800
In Commercial Distribution

  • 00709078013201 ()
  • 10709078013208 ()


  • PEEP valve, single-use
Balfour Retractor, 2" Spread, One Center Blade and One Pair Lateral Blades
MARINA MEDICAL INSTRUMENTS, INC.
110-422
In Commercial Distribution

  • 00840306816314 ()
110-422

  • Vascular dilator, reusable
One spike to one 3/8" barb with 12cm DMSO resistant tubing
ORIGEN BIOMEDICAL, INC.
S-38B12
In Commercial Distribution

  • 10816203021912 ()
  • 20816203021919 ()


  • Blood transfer set
VG BRT 3T 16CH TT GE750 FUL SET RISER w GRD contains contains one patient support assembly, one box of 10 sterilized biopsy grids, one Lateral array coil left and right coil, one Medial array coil, one Interface box, one Coil Single loop left and right, and one medial plug.
Philips Medical Systems Nederland B.V.
989603217131
In Commercial Distribution

  • 00884838119840 ()


  • MRI system coil, radio-frequency
LacriCATH kit DCR508-UNIT contains one lacrimal duct catheter 5mm, one AQL 1015 inflation device, and one LIS052 STENTube intubation device.
QUEST MEDICAL INC
DCR508-UNIT
In Commercial Distribution

  • 20634624438518 ()


  • Lacrimal intubation set
Contains one (1) 60 gram powder (N815102), one (1) 60 milliliter liquid (N814002), and one (1) 30 milliliter sealer (N816002)
Dentsply International Inc.
Soft Denture Liner 60 G Kit Clear
Not in Commercial Distribution

  • D001N8111000 ()
N811100

  • Dental appliance fabrication material, resin
Contains one (1) 60 gram powder (N815002), one (1) 60 milliliter liquid (N814002), and one (1) 30 milliliter sealer (N816002)
Dentsply International Inc.
Soft Denture Liner 60 G Kit Pink
Not in Commercial Distribution

  • D001N8110000 ()
N811000

  • Dental appliance fabrication material, resin
Sample pack contains one of each: 1) One by Poise Extra Coverage Liner (53451-00),2) One by Poise Heavy Pad (53452-00), 3) One by Poise Reg Pad (53453-00)
KIMBERLY-CLARK GLOBAL SALES, INC.
Pad
In Commercial Distribution

  • 00036000670035 ()


  • Menstrual pad, unscented
106900 Connex Server Application Software – Includes 2 thumb drives, one Production, one Test, with included software app, installer and Proview – Includes one ADT <(>&<)> one ORU production license, one ADT <(>&<)> one ORU test license – Includes 5 connectivity device test licenses – Includes Connex CS 1.8x DFU
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094244298 ()
106900

  • Centralized patient monitor
Medication management system
ONE WORLD DESIGN AND MANUFACTURING GROUP LTD
1
In Commercial Distribution

  • 00860000925907 ()


  • Personal pill dose dispenser, electric
Barrier, Absorbable, Adhesion
GENZYME CORPORATION
4301-02
In Commercial Distribution

  • 00358468430120 ()
  • 30358468430121 ()

  • one 13 cm x 15 cm membrane/pouch
  • Area/Surface Area: 195 Square centimeter


  • Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated
Barrier, Absorbable, Adhesion
GENZYME CORPORATION
6641-01
In Commercial Distribution

  • 00358468664112 ()
  • 30358468664113 ()

  • Area/Surface Area: 91 Square centimeter
  • one 7 cm x 13 cm membrane/pouch


  • Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated
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