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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This product is made by molding thermoplastic synthetic resin to the affected area, and is used to support and immobilize the joint and surrounding areas.
BM KOREA CO., LTD
GSL-L
In Commercial Distribution

  • 08809818038159 ()

  • Length: 355 Millimeter
  • Width: 120 Millimeter


  • First aid limb splint, non-mouldable, reusable
This product is made by molding thermoplastic synthetic resin to the affected area, and is used to support and immobilize the joint and surrounding areas.
BM KOREA CO., LTD
GLLC
In Commercial Distribution

  • 08809818038128 ()

  • Length: 430 Millimeter
  • Width: 125 Millimeter


  • First aid limb splint, non-mouldable, reusable
This product is made by molding thermoplastic synthetic resin to the affected area, and is used to support and immobilize the joint and surrounding areas.
BM KOREA CO., LTD
GLL
In Commercial Distribution

  • 08809818038111 ()

  • Length: 710 Millimeter
  • Width: 125 Millimeter


  • First aid limb splint, non-mouldable, reusable
Soleus Foot, Right, Jet Black, Midnight Black Housing, 25cm, Wide, Category 32
COLLEGE PARK INDUSTRIES, INC.
SO RJM 25W D32
In Commercial Distribution

  • 00195411299836 ()


  • Mechanical-resistance external ankle-foot prosthesis
Soleus Foot, Right, Tan, Tactical Housing, 21cm, Narrow, Category 32
COLLEGE PARK INDUSTRIES, INC.
SO RTT 21N D32
In Commercial Distribution

  • 00195411281503 ()


  • Mechanical-resistance external ankle-foot prosthesis
Soleus Foot, Left, Brown, Silver Housing, 27cm, Narrow, Category 34
COLLEGE PARK INDUSTRIES, INC.
SO LBS 27N D34
In Commercial Distribution

  • 00195411165261 ()


  • Mechanical-resistance external ankle-foot prosthesis
Soleus Foot, Left, Jet Black, Midnight Black Housing, 24cm, Narrow, Category 12
COLLEGE PARK INDUSTRIES, INC.
SO LJM 24N D12
In Commercial Distribution

  • 00195411183357 ()


  • Mechanical-resistance external ankle-foot prosthesis
Soleus Foot, Right, Jet Black, Perfect Pink Housing, 27cm, Wide, Category 12
COLLEGE PARK INDUSTRIES, INC.
SO RJP 27W D12
In Commercial Distribution

  • 00195411301539 ()


  • Mechanical-resistance external ankle-foot prosthesis
This product is made by molding thermoplastic synthetic resin to the affected area, and is used to support and immobilize the joint and surrounding areas.
BM KOREA CO., LTD
GSL-S
In Commercial Distribution

  • 08809818038135 ()

  • Length: 300 Millimeter
  • Width: 100 Millimeter


  • First aid limb splint, non-mouldable, reusable
3i T3® SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT WITH DCD®, 6MM(D) X 6MM(L)
BIOMET 3I, LLC
BNES606
In Commercial Distribution

  • 00844868033622 ()

  • Length: 6 Millimeter
  • Diameter 6 mm


  • Screw endosteal dental implant, two-piece
3i T3® SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT WITH DCD®, 5MM(D) X 6MM(L)
BIOMET 3I, LLC
BNES506
In Commercial Distribution

  • 00844868033608 ()

  • Length: 6 Millimeter
  • Diameter 5 mm


  • Screw endosteal dental implant, two-piece
3i T3® SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT WITH DCD®, 6MM(D) X 5MM(L)
BIOMET 3I, LLC
BNES605
In Commercial Distribution

  • 00844868033615 ()

  • Diameter 6 mm
  • Length: 5 Millimeter


  • Screw endosteal dental implant, two-piece
3i T3® SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT WITH DCD®, 5MM(D) X 5MM(L)
BIOMET 3I, LLC
BNES505
In Commercial Distribution

  • 00844868033592 ()

  • Length: 5 Millimeter
  • Diameter 5 mm


  • Screw endosteal dental implant, two-piece
Hemostatic Gauze: The device is indicated for temporary external use to control bleeding of lacerations, minor cuts and abrasions. Hemostatic gauze is for temporary external use only.
MEDTRADE PRODUCTS LIMITED
FG08834321
In Commercial Distribution

  • 35060206630261 ()
  • 15060206630267 ()
  • 75060206630269 ()

  • Supplied folded size 2in by 2in
  • Full dressing size 4in by 4in (10.2cm by 10.2cm)
  • Length: 4 Inch
  • Width: 4 Inch
FG08834321

  • Chitosan haemostatic agent, home-use
A custom manufactured Photon Beam Shaping Block for external beam radiation therapy.
DECIMAL, INC.
1.3
In Commercial Distribution

  • 00851147007045 ()


  • Radiation therapy beam block material
TCM4x Alice DE interface cable. Connecting cable to an external device (PSG).
Radiometer Medical ApS
903-340
Not in Commercial Distribution

  • 05700699033406 ()
903-340

  • Transcutaneous blood gas monitoring system
TCM4x Alice Int interface cable. Connecting cable to an external device (PSG)
Radiometer Medical ApS
903-180
In Commercial Distribution

  • 05700699031808 ()
903-180

  • Electrical-only medical device connection cable, reusable
Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials
TECHNOVENT LIMITED
AlSil Gum 80 Shore – 5kg
In Commercial Distribution

  • 05060483016238 ()
AL80B

  • External limb prosthesis finishing component, custom-made
Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials
TECHNOVENT LIMITED
AlSil Gum 60 Shore – 5kg
In Commercial Distribution

  • 05060483016221 ()
AL60B

  • External limb prosthesis finishing component, custom-made
Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials
TECHNOVENT LIMITED
AlSil Gum 35 Shore – 5kg
In Commercial Distribution

  • 05060483016214 ()
AL35B

  • External limb prosthesis finishing component, custom-made
Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials
TECHNOVENT LIMITED
AlSil Gum 20 Shore – 5kg
In Commercial Distribution

  • 05060483016207 ()
AL20B

  • External limb prosthesis finishing component, custom-made
Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials
TECHNOVENT LIMITED
AlSil Gum 10 Shore – 5kg
In Commercial Distribution

  • 05060483016191 ()
AL10B

  • External limb prosthesis finishing component, custom-made
Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials
TECHNOVENT LIMITED
AlSil Gum 80 Shore – 20kg
In Commercial Distribution

  • 05060483013138 ()
AL80C

  • External limb prosthesis finishing component, custom-made
Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials
TECHNOVENT LIMITED
AlSil Gum 80 Shore – 1kg
In Commercial Distribution

  • 05060483013114 ()
AL80A

  • External limb prosthesis finishing component, custom-made
Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials
TECHNOVENT LIMITED
AlSil Gum 60 Shore – 20kg
In Commercial Distribution

  • 05060483013107 ()
AL60C

  • External limb prosthesis finishing component, custom-made
Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials
TECHNOVENT LIMITED
AlSil Gum 60 Shore – 1kg
In Commercial Distribution

  • 05060483013084 ()
AL60A

  • External limb prosthesis finishing component, custom-made
Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials
TECHNOVENT LIMITED
AlSil Gum 35 Shore – 20kg
In Commercial Distribution

  • 05060483013077 ()
AL35C

  • External limb prosthesis finishing component, custom-made
Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials
TECHNOVENT LIMITED
AlSil Gum 35 Shore – 1kg
In Commercial Distribution

  • 05060483013053 ()
AL35A

  • External limb prosthesis finishing component, custom-made
Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials
TECHNOVENT LIMITED
AlSil Gum 20 Shore – 20kg
In Commercial Distribution

  • 05060483013046 ()
AL20C

  • External limb prosthesis finishing component, custom-made
Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials
TECHNOVENT LIMITED
AlSil Gum 20 Shore – 1kg
In Commercial Distribution

  • 05060483013022 ()
AL20A

  • External limb prosthesis finishing component, custom-made
Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials
TECHNOVENT LIMITED
AlSil Gum 10 Shore – 20kg
In Commercial Distribution

  • 05060483013015 ()
AL10C

  • External limb prosthesis finishing component, custom-made
Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials
TECHNOVENT LIMITED
AlSil Gum 10 Shore – 1kg
In Commercial Distribution

  • 05060483012995 ()
AL10A

  • External limb prosthesis finishing component, custom-made
Compatible with: 6.0mm external hex BIOMET 3i implants Implant Replica, Stainless Steel
DIAMODENT INC
N/A
In Commercial Distribution

  • D907D9000 ()
D900

  • Dental implant abutment analog, laboratory
Compatible with: 5.0mm external hex BIOMET 3i implants Implant Replica, Stainless Steel
DIAMODENT INC
N/A
In Commercial Distribution

  • D907C9000 ()
  • D907C9002 ()
C900

  • Dental implant abutment analog, laboratory
Male External Catheter,Standard One Piece Sheath Design with 2-Sided Adhesive Strap
Cardinal Health, Inc.
8884732500
Not in Commercial Distribution

  • 20884521004211 ()
  • 10884521004214 ()

  • Outer Diameter: 1.3 Inch
8884732500

  • Indwelling urethral catheterization kit, adult
Male External Catheter,Medium One Piece Sheath Design with 2-Sided Adhesive Strap
Cardinal Health, Inc.
8884732000
Not in Commercial Distribution

  • 20884521004013 ()
  • 10884521004016 ()

  • Outer Diameter: 1.1 Inch
8884732000

  • Indwelling urethral catheterization kit, adult
Durette IV External Laser Shields, patients goggles with all metal attachments, small
Hayden Medical, Inc.
OP21-552
In Commercial Distribution

  • 00840319732229 ()
OP21-552

  • Epiocular radiation shield, reusable
Durette IV External Laser Shields, patients goggles with all metal attachments, regular
Hayden Medical, Inc.
OP21-555
In Commercial Distribution

  • 00840319716625 ()
OP21-555

  • Epiocular radiation shield, reusable
UPGRADE FROM HALOG TO LED ERGOLITE LED W/ EXTERNAL 100-240 VAC POWER
AADCO MEDICAL, INC.
OSP-511LXUPGR
In Commercial Distribution

  • 00840348503937 ()
OSP-511LXUPGR

  • Custom-made medical device mount
MRI-Safe LED 75000 LUX LAM W/ EXTERNAL 120 VAC TO 24VDC TRANSFORMER
AADCO MEDICAL, INC.
OSP-511LXNF
In Commercial Distribution

  • 00840348503920 ()
OSP-511LXNF

  • Custom-made medical device mount
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