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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OPEN BACK GLASS HALO SM
OSSUR AMERICAS, INC.
505300V2
Not in Commercial Distribution

  • 05690977305915 ()
505300V2

  • Cervical spine immobilization system, single-use
CB RING KIT TI LG
OSSUR AMERICAS, INC.
505500T
Not in Commercial Distribution

  • 05690977305908 ()
505500T

  • Cervical spine immobilization head ring
CB RING KIT TI STD
OSSUR AMERICAS, INC.
505400T
Not in Commercial Distribution

  • 05690977305892 ()
505400T

  • Cervical spine immobilization head ring
CB RING KIT TI SM
OSSUR AMERICAS, INC.
505300T
Not in Commercial Distribution

  • 05690977305885 ()
505300T

  • Cervical spine immobilization head ring
Cold Rush Ankle Pad
OSSUR AMERICAS, INC.
B-232002500
In Commercial Distribution

  • 05690977304451 ()
B-232002500

  • Circulating-fluid localized thermal therapy system pack, single-use
OB V2 RING KIT TI LG
OSSUR AMERICAS, INC.
505500V2
Not in Commercial Distribution

  • 05690977223370 ()
505500V2

  • Cervical spine immobilization system, single-use
Cold Rush Lumbar Pad
OSSUR AMERICAS, INC.
B-232002404
In Commercial Distribution

  • 05690977198593 ()
B-232002404

  • Circulating-fluid localized thermal therapy system pack, single-use
Cold Rush Rectangular Pad Sml
OSSUR AMERICAS, INC.
B-232002402
In Commercial Distribution

  • 05690977198586 ()
B-232002402

  • Circulating-fluid localized thermal therapy system pack, single-use
Cold Rush Univ Pad
OSSUR AMERICAS, INC.
B-232002300
In Commercial Distribution

  • 05690977198579 ()
B-232002300

  • Circulating-fluid localized thermal therapy system pack, single-use
Cold Rush Shldr Pad LG
OSSUR AMERICAS, INC.
B-232002204
In Commercial Distribution

  • 05690977198562 ()
B-232002204

  • Circulating-fluid localized thermal therapy system pack, single-use
Cold Rush Shldr Pad SM
OSSUR AMERICAS, INC.
B-232002202
In Commercial Distribution

  • 05690977198555 ()
B-232002202

  • Circulating-fluid localized thermal therapy system pack, single-use
Cold Rush Hip Pad RT
OSSUR AMERICAS, INC.
B-232502100
In Commercial Distribution

  • 05690977198548 ()
B-232502100

  • Circulating-fluid localized thermal therapy system pack, single-use
Cold Rush Hip Pad LT
OSSUR AMERICAS, INC.
B-232602100
In Commercial Distribution

  • 05690977198531 ()
B-232602100

  • Circulating-fluid localized thermal therapy system pack, single-use
Cold Rush Knee Pad
OSSUR AMERICAS, INC.
B-232002000
In Commercial Distribution

  • 05690977198524 ()
B-232002000

  • Circulating-fluid localized thermal therapy system pack, single-use
Cold Rush Device USA
OSSUR AMERICAS, INC.
B-232000010
In Commercial Distribution

  • 05690977198517 ()
B-232000010

  • Circulating-fluid localized thermal therapy system control unit
OB RESOLVE COMPONENT TRAY
OSSUR AMERICAS, INC.
540D
Not in Commercial Distribution

  • 05690977197404 ()
540D

  • Cervical spine immobilization head ring
OB RESOLVE STERILE UNIT LGE
OSSUR AMERICAS, INC.
505500D
Not in Commercial Distribution

  • 05690977197336 ()
505500D

  • Cervical spine immobilization head ring
OB RESOLVE STERILE UNIT STD
OSSUR AMERICAS, INC.
505400D
Not in Commercial Distribution

  • 05690977197329 ()
505400D

  • Cervical spine immobilization head ring
OB RESOLVE STERILE UNIT SML
OSSUR AMERICAS, INC.
505300D
Not in Commercial Distribution

  • 05690977197312 ()
505300D

  • Cervical spine immobilization head ring
J TONG ONLY SML/MED
OSSUR AMERICAS, INC.
JT-210
Not in Commercial Distribution

  • 05690977197305 ()
JT-210

  • Traction system skull tongs
J TONG ONLY MED/LGE
OSSUR AMERICAS, INC.
JT-110
Not in Commercial Distribution

  • 05690977197299 ()
JT-110

  • Traction system skull tongs
J TONG ASSEMBLY SML/MED
OSSUR AMERICAS, INC.
JT-200
Not in Commercial Distribution

  • 05690977197282 ()
JT-200

  • Traction system skull tongs
J TONG ASSEMBLY MED/LGE
OSSUR AMERICAS, INC.
JT-100
Not in Commercial Distribution

  • 05690977197275 ()
JT-100

  • Traction system skull tongs
HALO APPLICATION TRAY
OSSUR AMERICAS, INC.
538
Not in Commercial Distribution

  • 05690977196636 ()
538

  • Cervical spine immobilization head ring
Skull Pin 2-1/4in CT Sterl 1PK
OSSUR AMERICAS, INC.
516CS
Not in Commercial Distribution

  • 05690977194090 ()
516CS

  • Cervical spine immobilization head ring rod
RESOLVE TRACTION HOOP
OSSUR AMERICAS, INC.
515C4
Not in Commercial Distribution

  • 05690977193192 ()
515C4

  • Cervical spine immobilization system, single-use
J TONG COMPONENT TRAY
OSSUR AMERICAS, INC.
JT-400
Not in Commercial Distribution

  • 05690977193123 ()
JT-400

  • Traction system skull tongs
Skull Pin 3in CT Sterl 4 PK
OSSUR AMERICAS, INC.
517DS
Not in Commercial Distribution

  • 05690977192577 ()
517DS

  • Cervical spine immobilization head ring rod
STERILE V2 COMPONENT TRAY
OSSUR AMERICAS, INC.
540V2
Not in Commercial Distribution

  • 05690977192348 ()
540V2

  • Cervical spine immobilization head ring
RESOLVE HALO COMP TRAY
OSSUR AMERICAS, INC.
540C
Not in Commercial Distribution

  • 05690977165335 ()
540C

  • Cervical spine immobilization head ring
HALO RINGS LG
OSSUR AMERICAS, INC.
505500C
Not in Commercial Distribution

  • 05690977164130 ()
505500C

  • Cervical spine immobilization head ring
HALO RINGS MDIUM
OSSUR AMERICAS, INC.
505400C
Not in Commercial Distribution

  • 05690977164116 ()
505400C

  • Cervical spine immobilization head ring
HALO RINGS SM
OSSUR AMERICAS, INC.
505300C
Not in Commercial Distribution

  • 05690977164093 ()
505300C

  • Cervical spine immobilization head ring
Skull Pin 2-1/4in CT Sterl 4PK
OSSUR AMERICAS, INC.
517CS
Not in Commercial Distribution

  • 05690977084544 ()
517CS

  • Cervical spine immobilization head ring rod
Skull Pin 3in CT Sterl 1PK
OSSUR AMERICAS, INC.
516DS
Not in Commercial Distribution

  • 05690977084490 ()
516DS

  • Cervical spine immobilization head ring rod
Skull Pin 2-1/4in TI Sterl 1PK
OSSUR AMERICAS, INC.
516TS
Not in Commercial Distribution

  • 05690977084469 ()
516TS

  • Cervical spine immobilization head ring rod
SKULL PIN 2-1/4 CT 6 PK
OSSUR AMERICAS, INC.
522C
Not in Commercial Distribution

  • 05690977084254 ()
522C

  • Cervical spine immobilization head ring rod
SYMBIONIC LEG 3 TRIAL 22-24
OSSUR AMERICAS, INC.
SBL13211
Not in Commercial Distribution

  • 05690967600686 ()
SBL13211

  • Mechatronic external knee prosthesis
SYMBIONIC LEG 3 TRIAL 25-30
OSSUR AMERICAS, INC.
SBL13210
Not in Commercial Distribution

  • 05690967600679 ()
SBL13210

  • Dynamic-response foot prosthesis
  • Knee-disarticulation prosthesis
SYMBIONIC LEG 3 LOANER 22-24
OSSUR AMERICAS, INC.
SBL13111
Not in Commercial Distribution

  • 05690967600662 ()
SBL13111

  • Mechatronic external knee prosthesis
SYMBIONIC LEG 3 LOANER 25-30
OSSUR AMERICAS, INC.
SBL13110
Not in Commercial Distribution

  • 05690967600655 ()
SBL13110

  • Mechatronic external knee prosthesis
RHEO KNEE 3 TRIAL
OSSUR AMERICAS, INC.
RKN13200
Not in Commercial Distribution

  • 05690967600600 ()
RKN13200

  • Mechatronic external knee prosthesis
RHEO KNEE 3 Trials
OSSUR AMERICAS, INC.
RKN130203
Not in Commercial Distribution

  • 05690967595425 ()
RKN130203

  • Mechatronic external knee prosthesis
POWER KNEE G2 KIT NA 5 yr warr
OSSUR AMERICAS, INC.
PKN120017
Not in Commercial Distribution

  • 05690967584795 ()
PKN120017

  • Mechatronic external knee prosthesis
SYMBIONIC LEG LOANER 25-30
OSSUR AMERICAS, INC.
SBL12102
Not in Commercial Distribution

  • 05690967567590 ()
SBL12102

  • Knee-disarticulation prosthesis
  • Dynamic-response foot prosthesis
SYMBIONIC LEG LOANER 22-24
OSSUR AMERICAS, INC.
SBL12112
Not in Commercial Distribution

  • 05690967567583 ()
SBL12112

  • Mechatronic external knee prosthesis
KIT POWERSUPPLY PROPRIO/RHEO
OSSUR AMERICAS, INC.
PRX00421
Not in Commercial Distribution

  • 05690967514341 ()
PRX00421

  • Basic power supply, reusable
No Description
SWORD HEALTH, S.A.
6
In Commercial Distribution

  • 05600775530563 ()


  • Pelvic floor muscle exerciser
No Description
SWORD HEALTH, S.A.
SWORDPhoenix-54
In Commercial Distribution

  • 05600775530549 ()


  • Virtual-display rehabilitation system, non-supportive, home-use
No Description
SWORD HEALTH, S.A.
SWORDPhoenix-53
In Commercial Distribution

  • 05600775530532 ()


  • Virtual-display rehabilitation system, non-supportive, home-use
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