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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Mouthpiece, Disposable, 1-1/8" O.D., 2.625" L
A-M SYSTEMS, LLC
Mouthpiece, 1-1/8" O.D., 2.625" L - 162502
In Commercial Distribution

  • 00817081023725 ()
  • 00817081023718 ()
162502

  • Breathing mouthpiece, single-use
Mouthpiece, Disposable, 1-1/8" O.D., 2.625" L
A-M SYSTEMS, LLC
Mouthpiece, 1-1/8" O.D., 2.625" L - 162500
In Commercial Distribution

  • 00817081023688 ()
  • 00817081023671 ()
162500

  • Breathing mouthpiece, single-use
Mouthpiece, Disposable, 1-1/16" O.D., 2.625" L
A-M SYSTEMS, LLC
Mouthpiece, 1-1/16" O.D., 2.625" L - 162402
In Commercial Distribution

  • 00817081023664 ()
  • 00817081023657 ()
162402

  • Breathing mouthpiece, single-use
Mouthpiece, Disposable, 1-1/16" O.D., 2.625" L
A-M SYSTEMS, LLC
Mouthpiece, 1-1/16" O.D., 2.625" L - 162400
In Commercial Distribution

  • 00817081023640 ()
  • 00817081023633 ()
162400

  • Breathing mouthpiece, single-use
11 1/2" Browne Deltoid Retractor, 57mm
Surgical Direct, Inc.
SD922862107
In Commercial Distribution

  • B382SD9228621070 ()
SD922862107

  • Self-retaining surgical retractor, reusable
11 5/8" Cobb Osteotome, Curved 16mm
Surgical Direct, Inc.
SD921951103
In Commercial Distribution

  • B382SD9219511030 ()
SD921951103

  • Orthopaedic osteotome
11" Cobb Osteotome, Straight Blade 3/4"
Surgical Direct, Inc.
SD921951102
In Commercial Distribution

  • B382SD9219511020 ()
SD921951102

  • Orthopaedic osteotome
Lid Speculum 1-1/4", Closed Wire Blades
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-595
Not in Commercial Distribution

  • H834185950 ()
  • 10381780463658 ()
18-595

  • Eyelid speculum, reusable
VAL Screw, 2.7 mm x 11 mm
ARTHREX, INC.
AR-18827V-11
In Commercial Distribution

  • 00888867386839 ()
AR-18827V-11

  • Orthopaedic bone screw (non-sliding)
Cortical Screw, 2.7 mm x 11 mm
ARTHREX, INC.
AR-18827-11
In Commercial Distribution

  • 00888867386495 ()
AR-18827-11

  • Orthopaedic bone screw (non-sliding)
2.8 TriLock Distal FibulaPlate,11 Hole Straight
Medartis AG
A-4854.07S
In Commercial Distribution

  • 07630037831075 ()
A-4854.07S

  • Orthopaedic fixation plate, non-bioabsorbable
2.8 TriLock Distal FibulaPlate,11 Hole Straight
Medartis AG
A-4854.07
In Commercial Distribution

  • 07630037829003 ()
A-4854.07

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Cobb Spinal Elev, 11", 5/8" wide
BOSS INSTRUMENTS, LTD., INC.
72-1063
In Commercial Distribution

  • 00888515301832 ()
72-1063

  • Bone lever/elevator, reusable
SHARP-COAT SPURLING KERRISON, 40DEG UP, 11", 2MM
BOSS INSTRUMENTS, LTD., INC.
SS6283
In Commercial Distribution

  • 00888515274730 ()
SS6283

  • Spinal rongeur
11 Inch Clip Applier, Light Blue, Angled
Surgical Direct, Inc.
SD32152829
In Commercial Distribution

  • B382SD321528290 ()
SD32152829

  • Open-surgery ligation clip applier
Primary Extension Stem Ø 11, 30 mm
Medacta International SA
02.07.F11030
In Commercial Distribution

  • 07630030822643 ()


  • Knee femur stem prosthesis
HTO IMPL,IBAL SM 13°/MED 11°
ARTHREX, INC.
AR-13400M-11
In Commercial Distribution

  • 00888867011861 ()
  • M150AR13400M111 ()
AR-13400M-11

  • Orthopaedic fixation plate, non-bioabsorbable
HTO IMPL,IBAL SM 11°/MED 10°
ARTHREX, INC.
AR-13400M-10
In Commercial Distribution

  • 00888867011854 ()
  • M150AR13400M101 ()
AR-13400M-10

  • Orthopaedic fixation plate, non-bioabsorbable
HTO IMPL,IBAL LG 12°/X-LG 11°
ARTHREX, INC.
AR-13400L-12
In Commercial Distribution

  • 00888867011755 ()
  • M150AR13400L121 ()
AR-13400L-12

  • Orthopaedic fixation plate, non-bioabsorbable
HTO IMPL,IBAL LG 11°/X-LG 10°
ARTHREX, INC.
AR-13400L-11
In Commercial Distribution

  • 00888867011748 ()
  • M150AR13400L111 ()
AR-13400L-11

  • Orthopaedic fixation plate, non-bioabsorbable
TIB OPEN WEDGE OSTEO PLATE, 11 MM
ARTHREX, INC.
AR-13200-11.0S
In Commercial Distribution

  • 00888867008687 ()
  • M150AR13200110S1 ()
AR-13200-11.0S

  • Orthopaedic fixation plate, non-bioabsorbable
11 MM TIBIAL OPENING WEDGE OSTEO PLATE
ARTHREX, INC.
AR-13200-11.0
In Commercial Distribution

  • 00888867008670 ()
  • M150AR132001100 ()
AR-13200-11.0

  • Orthopaedic fixation plate, non-bioabsorbable
SPKD LGMNT STAPLE 11 MMX 20 MMLG
ARTHREX, INC.
AR-1011
In Commercial Distribution

  • 00888867002548 ()
  • M150AR10111 ()
AR-1011

  • Surgical staple loading unit, non-cutting
Brand Tendon Stripper, 3mm, 11 3/4"
BOSS INSTRUMENTS, LTD., INC.
96-5762
In Commercial Distribution

  • 00888515253100 ()
96-5762

  • Tendon stripper
Open Wire Temporal Approach Speculum, 1-1/2"
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-44
Not in Commercial Distribution

  • H83418440 ()
  • 10381780509806 ()
18-44

  • Eyelid speculum, reusable
Bone Curette, Miller 11, Tactile Tone™
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
TKM11
Not in Commercial Distribution

  • H834TKM110 ()
  • 10381780508182 ()
TKM11

  • Periodontal curette
55 x 11 x 3.1mm, 8 Flute
SURETEK MEDICAL
16-S0621
In Commercial Distribution

  • B39016S06211 ()


  • Orthopaedic bur, single-use
Cannula w/ Elevator Tip: 11 x 134mm
ARTHREX, INC.
AR-S3420-110-134ET
In Commercial Distribution

  • 00888867463929 ()
AR-S3420-110-134ET

  • Arthroscopic access cannula, reusable
Cannula w/ Flat Tip: 11 x 134mm
ARTHREX, INC.
AR-S3420-110-134FT
In Commercial Distribution

  • 00888867427877 ()
AR-S3420-110-134FT

  • Bone grafting cannula
Cannula w/ Oblique Window:11 x 134mm
ARTHREX, INC.
AR-S3420-110-134
In Commercial Distribution

  • 00888867427860 ()
AR-S3420-110-134

  • Endoscope sheath, reusable
Strap, 11 Point w/ Refl. Tape, Blue
MEDSOURCE INTERNATIONAL LLC
MS-ST11PTR
In Commercial Distribution

  • 00816703028087 ()
Not Applicable

  • Limb/torso/head restraint, reusable
S-ROM DISTAL STEM TRIAL, STANDARD SIZE 11
DEPUY ORTHOPAEDICS, INC.
2576-11-100
In Commercial Distribution

  • 10603295146063 ()
257611100

  • Femoral stem prosthesis trial
Shaver Short - Right / 210 mm - h.11
Medacta International SA
03.22.10.1104
In Commercial Distribution

  • 07630040792332 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Trial Tibial Insert Flex S6R - 11 mm
Medacta International SA
02.12.10.0182
In Commercial Distribution

  • 07630040779586 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Trial Tibial Insert Flex S6L - 11 mm
Medacta International SA
02.12.10.0180
In Commercial Distribution

  • 07630040779562 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Trial Tibial Insert Flex S5R - 11 mm
Medacta International SA
02.12.10.0178
In Commercial Distribution

  • 07630040779548 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Trial Tibial Insert Flex S5L - 11 mm
Medacta International SA
02.12.10.0176
In Commercial Distribution

  • 07630040779524 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Trial Tibial Insert Flex S4R - 11 mm
Medacta International SA
02.12.10.0174
In Commercial Distribution

  • 07630040779500 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Trial Tibial Insert Flex S4L - 11 mm
Medacta International SA
02.12.10.0172
In Commercial Distribution

  • 07630040779487 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Trial Tibial Insert Flex S3R - 11 mm
Medacta International SA
02.12.10.0170
In Commercial Distribution

  • 07630040779463 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
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