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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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Humeral Cup Stability - 03701037309407

HUMERAL CUP STABILITY PE/TA6V Ø32/+9
FX SOLUTIONS
102-1009
In Commercial Distribution

  • 03701037309407 ()
102-1009

  • Polyethylene reverse shoulder prosthesis cup

32mm Glenosphere and Humeral Cup - 03701037309377

HUMERAL CUP STANDARD PE/TA6V Ø32/+9
FX SOLUTIONS
102-0809
In Commercial Distribution

  • 03701037309377 ()


  • Polyethylene reverse shoulder prosthesis cup

Humelock II Cemented Reversible Shoulder - 03701037303498

TRIAL HUMERAL CUP 135/145° Ø40+9
FX SOLUTIONS
904-0809
In Commercial Distribution

  • 03701037303498 ()
904-0809

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Humelock II Cemented Reversible Shoulder - 03701037302866

HUMERAL CUP MOBILITY PE/TA6V Ø40/+9
FX SOLUTIONS
104-0609
In Commercial Distribution

  • 03701037302866 ()

  • Height: 9 Millimeter
104-0609

  • Polyethylene reverse shoulder prosthesis cup

Humelock II Cemented Reversible Shoulder - 03701037302835

HUMERAL CUP MOBILITY PE/TA6V Ø36/+9
FX SOLUTIONS
103-0609
In Commercial Distribution

  • 03701037302835 ()

  • Height: 9 Millimeter
103-0609

  • Polyethylene reverse shoulder prosthesis cup

Humelock II Cemented Reversible Shoulder - 03701037300145

HUMERAL CUP STANDARD PE/TA6V Ø40/+9
FX SOLUTIONS
104-0809
In Commercial Distribution

  • 03701037300145 ()

  • Height: 9 Millimeter
104-0809

  • Polyethylene reverse shoulder prosthesis cup

Humelock II Cemented Reversible Shoulder - 03701037300114

HUMERAL CUP STANDARD PE/TA6V Ø36/+9
FX SOLUTIONS
103-0809
In Commercial Distribution

  • 03701037300114 ()

  • Height: 9 Millimeter
103-0809

  • Polyethylene reverse shoulder prosthesis cup

Ambler Surgical - 00190660212100

Rowe's zygomatic bone elevator, 9 7/8''
AMBLER SURGICAL CORP.
Rowe's zygomatic bone elevator
In Commercial Distribution

  • 00190660212100 ()
20-927

  • ENT elevator

Buccal Tubes - 00840273904014

DBT UL6 18/No/-14/+9 5PK
World Class Technology Corporation
907.1023-5
In Commercial Distribution

  • 00840273904014 ()
907.1023-5

  • Orthodontic tube

Buccal Tubes - 00840273904007

DBT UR6 18/No/-14/+9 5PK
World Class Technology Corporation
907.1022-5
In Commercial Distribution

  • 00840273904007 ()
907.1022-5

  • Orthodontic tube

Buccal Tubes - 00840273903178

DBT UR6 22/No/-14/+9 100PK
World Class Technology Corporation
907.2022-100
In Commercial Distribution

  • 00840273903178 ()
907.2022-100

  • Orthodontic tube

Buccal Tubes - 00840273902362

DBT UL6 18/No/-14/+9 100PK
World Class Technology Corporation
907.1023-100
In Commercial Distribution

  • 00840273902362 ()
907.1023-100

  • Orthodontic tube

Buccal Tubes - 00840273902355

DBT UR6 18/No/-14/+9 100PK
World Class Technology Corporation
907.1022-100
In Commercial Distribution

  • 00840273902355 ()
907.1022-100

  • Orthodontic tube

Buccal Tubes - 00840273902232

DBT UR6 18/No/0/+9 100PK
World Class Technology Corporation
907.1010-100
In Commercial Distribution

  • 00840273902232 ()
907.1010-100

  • Orthodontic tube

H4 - 00840273901792

H4 UL2 22/8/9/0 10PK
World Class Technology Corporation
916.2004-10
In Commercial Distribution

  • 00840273901792 ()
916.2004-10

  • Orthodontic bracket, metal

BioMIM Mini Twin Brackets - 00840273901655

MB UL2 22/+8/+9/0 100PK
World Class Technology Corporation
901.2004-100
In Commercial Distribution

  • 00840273901655 ()
901.2004-100

  • Orthodontic bracket, metal

BioMIM Mini Twin Brackets - 00840273901648

MB UR2 22/+8/+9/0 100PK
World Class Technology Corporation
901.2003-100
In Commercial Distribution

  • 00840273901648 ()
901.2003-100

  • Orthodontic bracket, metal

BioMIM Mini Twin Brackets - 00840273901419

MB UL2 18/+8/+9/0 100PK
World Class Technology Corporation
901.1004-100
In Commercial Distribution

  • 00840273901419 ()
901.1004-100

  • Orthodontic bracket, metal

BioMIM Mini Twin Brackets - 00840273901402

MB UR2 18/+8/+9/0 100PK
World Class Technology Corporation
901.1003-100
In Commercial Distribution

  • 00840273901402 ()
901.1003-100

  • Orthodontic bracket, metal

BioMIM Mini Twin Brackets - 00840273901150

MB UL2 22/+8/+9/0 10PK
World Class Technology Corporation
901.2004-10
In Commercial Distribution

  • 00840273901150 ()
901.2004-10

  • Orthodontic bracket, metal

BioMIM Mini Twin Brackets - 00840273901143

MB UL2 22/+8/+9/0 10PK
World Class Technology Corporation
901.2003-10
In Commercial Distribution

  • 00840273901143 ()
901.2003-10

  • Orthodontic bracket, metal

BioMIM Mini Twin Brackets - 00840273900894

MB UL2 18/+8/+9/0 10PK
World Class Technology Corporation
901.1004-10
In Commercial Distribution

  • 00840273900894 ()
901.1004-10

  • Orthodontic bracket, metal

BioMIM Mini Twin Brackets - 00840273900887

MB UR2 18/+8/+9/0 10PK
World Class Technology Corporation
901.1003-10
In Commercial Distribution

  • 00840273900887 ()
901.1003-10

  • Orthodontic bracket, metal

Pitts21 - 00840273900627

P21 UL2 21/6/9/0 10PK
World Class Technology Corporation
946.2004-10
In Commercial Distribution

  • 00840273900627 ()
946.2004-10

  • Orthodontic bracket, metal

Pitts21 - 00840273900610

P21 UR2 21/6/9/0 10PK
World Class Technology Corporation
946.2003-10
In Commercial Distribution

  • 00840273900610 ()
946.2003-10

  • Orthodontic bracket, metal

H4 - 00840273900252

H4 UR2 22/8/9/0 10PK
World Class Technology Corporation
916.2003-10
In Commercial Distribution

  • 00840273900252 ()
916.2003-10

  • Orthodontic bracket, metal

Clear21 - 00840273900030

C21 UL2 21/6/9/0 5PK
World Class Technology Corporation
246.2004-5
In Commercial Distribution

  • 00840273900030 ()


  • Orthodontic bracket, ceramic

Clear21 - 00840273900023

C21 UR2 21/6/9/0 5PK
World Class Technology Corporation
246.2003-5
In Commercial Distribution

  • 00840273900023 ()


  • Orthodontic bracket, ceramic

Anmuth Medical International - 08403207513236

SIMS Scss Sharp/Blunt Cvd 23cm/9"
Anmuth Medical International, LLC
11-513-23
In Commercial Distribution

  • 08403207513236 ()

  • Length: 9 Inch
11-513-23

  • General-purpose surgical scissors, reusable

Anmuth Medical International - 08403207510235

SIMS Scss Blunt/Blunt Str 23cm/9"
Anmuth Medical International, LLC
11-510-23
In Commercial Distribution

  • 08403207510235 ()

  • Length: 9 Inch
11-510-23

  • General-purpose surgical scissors, reusable

Anmuth Medical International - 08403207010100

Side Wire Cutter D/A 23cm/9"
Anmuth Medical International, LLC
39-541-23TC
In Commercial Distribution

  • 08403207010100 ()

  • Length: 9 Inch
39-541-23TC

  • Orthopaedic implantable-device cutter

Anmuth Medical International - 08403207007803

Mini-Lambotte Osteotome Set of 9 in Case
Anmuth Medical International, LLC
38-654-01
In Commercial Distribution

  • 08403207007803 ()

  • Length: 8 Inch
38-654-01

  • Orthopaedic osteotome

Anmuth Medical International - 08403207005298

DEBAKEY Needle Holder Slender TC 23cm/9"
Anmuth Medical International, LLC
30-230-23TC
In Commercial Distribution

  • 08403207005298 ()

  • Length: 9 Inch
30-230-23TC

  • Suturing needle holder, reusable

Anmuth Medical International - 08403207003492

OLLIER Retractor 4 Teeth Blunt 22.5cm/9"
Anmuth Medical International, LLC
24-360-04
In Commercial Distribution

  • 08403207003492 ()

  • Length: 9 Inch
24-360-04

  • Hand-held surgical retractor, reusable

Anmuth Medical International - 08403207937230

BRUNS Utility Shears w/ Teeth 23cm/9"
Anmuth Medical International, LLC
11-937-23
In Commercial Distribution

  • 08403207937230 ()

  • Length: 9 Inch
11-937-23

  • General-purpose surgical scissors, reusable

Anmuth Medical International - 08403207006370

LEKSELL-STILLE Bone Rongeur 4mm Jaw 23cm/9"
Anmuth Medical International, LLC
38-247-23
In Commercial Distribution

  • 08403207006370 ()

  • Length: 9 Inch
38-247-23

  • Orthopaedic joint/limb rongeur

Anmuth Medical International - 08403207006363

LEKSELL-STILLE Bone Rongeur 7mm Jaw 23cm/9"
Anmuth Medical International, LLC
38-245-23
In Commercial Distribution

  • 08403207006363 ()

  • Length: 9 Inch
38-245-23

  • Orthopaedic joint/limb rongeur

Peri-Loc - 03596010527714

4.5MM NARROW COMPRESSION PLATE 9 HOLE 178MM
Smith & Nephew, Inc.
71829459
In Commercial Distribution

  • 03596010527714 ()
71829459

  • Orthopaedic fixation plate, non-bioabsorbable

Peri-Loc - 03596010526038

3.5MM SMALL COMPRESSION PLATE 9 HOLE 132MM
Smith & Nephew, Inc.
71829409
In Commercial Distribution

  • 03596010526038 ()
71829409

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Peri-Loc - 03596010523433

3.5MM SMALL COMPRESSION PLATE 9 HOLE 132MM
Smith & Nephew, Inc.
71809409
In Commercial Distribution

  • 03596010523433 ()
71809409

  • Orthopaedic fixation plate, non-bioabsorbable
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