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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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Halo Systems - 05690977305885

CB RING KIT TI SM
OSSUR AMERICAS, INC.
505300T
Not in Commercial Distribution

  • 05690977305885 ()
505300T

  • Cervical spine immobilization head ring

Cold Rush - 05690977304451

Cold Rush Ankle Pad
OSSUR AMERICAS, INC.
B-232002500
In Commercial Distribution

  • 05690977304451 ()
B-232002500

  • Circulating-fluid localized thermal therapy system pack, single-use

Halo Systems - 05690977223370

OB V2 RING KIT TI LG
OSSUR AMERICAS, INC.
505500V2
Not in Commercial Distribution

  • 05690977223370 ()
505500V2

  • Cervical spine immobilization system, single-use

Cold Rush - 05690977198593

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 - 05690977198586

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 - 05690977198579

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 - 05690977198562

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 - 05690977198555

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 - 05690977198548

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 - 05690977198531

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 - 05690977198524

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 - 05690977198517

Cold Rush Device USA
OSSUR AMERICAS, INC.
B-232000010
In Commercial Distribution

  • 05690977198517 ()
B-232000010

  • Circulating-fluid localized thermal therapy system control unit

Halo Systems - 05690977197404

OB RESOLVE COMPONENT TRAY
OSSUR AMERICAS, INC.
540D
Not in Commercial Distribution

  • 05690977197404 ()
540D

  • Cervical spine immobilization head ring

Halo Systems - 05690977197336

OB RESOLVE STERILE UNIT LGE
OSSUR AMERICAS, INC.
505500D
Not in Commercial Distribution

  • 05690977197336 ()
505500D

  • Cervical spine immobilization head ring

Halo Systems - 05690977197329

OB RESOLVE STERILE UNIT STD
OSSUR AMERICAS, INC.
505400D
Not in Commercial Distribution

  • 05690977197329 ()
505400D

  • Cervical spine immobilization head ring

Halo Systems - 05690977197312

OB RESOLVE STERILE UNIT SML
OSSUR AMERICAS, INC.
505300D
Not in Commercial Distribution

  • 05690977197312 ()
505300D

  • Cervical spine immobilization head ring

Halo Systems - 05690977197305

J TONG ONLY SML/MED
OSSUR AMERICAS, INC.
JT-210
Not in Commercial Distribution

  • 05690977197305 ()
JT-210

  • Traction system skull tongs

Halo Systems - 05690977197299

J TONG ONLY MED/LGE
OSSUR AMERICAS, INC.
JT-110
Not in Commercial Distribution

  • 05690977197299 ()
JT-110

  • Traction system skull tongs

Halo Systems - 05690977197282

J TONG ASSEMBLY SML/MED
OSSUR AMERICAS, INC.
JT-200
Not in Commercial Distribution

  • 05690977197282 ()
JT-200

  • Traction system skull tongs

Halo Systems - 05690977197275

J TONG ASSEMBLY MED/LGE
OSSUR AMERICAS, INC.
JT-100
Not in Commercial Distribution

  • 05690977197275 ()
JT-100

  • Traction system skull tongs

Halo Systems - 05690977196636

HALO APPLICATION TRAY
OSSUR AMERICAS, INC.
538
Not in Commercial Distribution

  • 05690977196636 ()
538

  • Cervical spine immobilization head ring

Halo Systems - 05690977194090

Skull Pin 2-1/4in CT Sterl 1PK
OSSUR AMERICAS, INC.
516CS
Not in Commercial Distribution

  • 05690977194090 ()
516CS

  • Cervical spine immobilization head ring rod

Halo Systems - 05690977193192

RESOLVE TRACTION HOOP
OSSUR AMERICAS, INC.
515C4
Not in Commercial Distribution

  • 05690977193192 ()
515C4

  • Cervical spine immobilization system, single-use

Halo Systems - 05690977193123

J TONG COMPONENT TRAY
OSSUR AMERICAS, INC.
JT-400
Not in Commercial Distribution

  • 05690977193123 ()
JT-400

  • Traction system skull tongs

Halo Systems - 05690977192577

Skull Pin 3in CT Sterl 4 PK
OSSUR AMERICAS, INC.
517DS
Not in Commercial Distribution

  • 05690977192577 ()
517DS

  • Cervical spine immobilization head ring rod

Halo Systems - 05690977192348

STERILE V2 COMPONENT TRAY
OSSUR AMERICAS, INC.
540V2
Not in Commercial Distribution

  • 05690977192348 ()
540V2

  • Cervical spine immobilization head ring

Halo Systems - 05690977165335

RESOLVE HALO COMP TRAY
OSSUR AMERICAS, INC.
540C
Not in Commercial Distribution

  • 05690977165335 ()
540C

  • Cervical spine immobilization head ring

Halo Systems - 05690977164130

HALO RINGS LG
OSSUR AMERICAS, INC.
505500C
Not in Commercial Distribution

  • 05690977164130 ()
505500C

  • Cervical spine immobilization head ring

Halo Systems - 05690977164116

HALO RINGS MDIUM
OSSUR AMERICAS, INC.
505400C
Not in Commercial Distribution

  • 05690977164116 ()
505400C

  • Cervical spine immobilization head ring

Halo Systems - 05690977164093

HALO RINGS SM
OSSUR AMERICAS, INC.
505300C
Not in Commercial Distribution

  • 05690977164093 ()
505300C

  • Cervical spine immobilization head ring
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