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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BULLSEYE FEMORAL GUIDE, 10 MM/11 MM
Conmed Corporation
C8670
In Commercial Distribution

  • 10845854034309 ()
  • 20845854034306 ()

  • 10MM/11MM
C8670

  • Surgical drill guide, reusable
RECTANGULAR PATELLAR TENDOR GRAFT TEMPLATE, 11 MM
Conmed Corporation
8724
In Commercial Distribution

  • 10845854025482 ()
  • 20845854025489 ()
8724

  • Surgical drill guide, reusable
SWR KIT RPT CENTER SSPRO VER 11
Carefusion Corporation
28482-001
Not in Commercial Distribution

  • 10846446032628 ()
28482-001

  • Home-use sleep apnoea recording system
CRYSTAL® 11” LOW PROFILE IMPLANT INSERTER
SPINAL ELEMENTS, INC.
20013-008
In Commercial Distribution

  • 00840606134439 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SWR KIT SSPRO NEW SYS VER 11
Carefusion Corporation
28477-001
Not in Commercial Distribution

  • 10846446032611 ()
28477-001

  • Home-use sleep apnoea recording system
ACQ STN 1 BED Z4 VER 11
Carefusion Corporation
28484-001
Not in Commercial Distribution

  • 10846446032598 ()
28484-001

  • Polysomnography analyser
Frazier Monopolar Suction Coagulator 11" WL 10FR
Avalign Technologies, Inc.
72-37501110
In Commercial Distribution

  • 00190776159894 ()


  • ENT surgical procedure kit, non-medicated, reusable
Kogan Endocervical Speculum, 11", with ratchet & gauge
Avalign Technologies, Inc.
1-301351
In Commercial Distribution

  • 00190776390945 ()


  • Vaginal speculum, reusable
Bayonet #3 Knife Handle, 11", vertical blade
Avalign Technologies, Inc.
1-80131311
In Commercial Distribution

  • 00190776381417 ()


  • Ophthalmic knife, reusable
HEGAR DILATOR DOUBLE END 11" 25mm/26mm
Avalign Technologies, Inc.
1-7022526C
In Commercial Distribution

  • 00190776380441 ()


  • Fixed-diameter cervical dilator, reusable
HEGAR DILATOR DOUBLE END 11" 23mm/24mm
Avalign Technologies, Inc.
1-7022324C
In Commercial Distribution

  • 00190776380434 ()


  • Fixed-diameter cervical dilator, reusable
HEGAR DILATOR DOUBLE END 11" 21mm/22mm
Avalign Technologies, Inc.
1-7022122C
In Commercial Distribution

  • 00190776380427 ()


  • Fixed-diameter cervical dilator, reusable
HEGAR DILATOR DOUBLE END 11" 15mm/16mm
Avalign Technologies, Inc.
1-7021516C
In Commercial Distribution

  • 00190776380410 ()


  • Fixed-diameter cervical dilator, reusable
HEGAR DILATOR DOUBLE END 11" 13mm/14mm
Avalign Technologies, Inc.
1-7021314C
In Commercial Distribution

  • 00190776380403 ()


  • Fixed-diameter cervical dilator, reusable
HEGAR DILATOR DOUBLE END 11" 9mm/10mm
Avalign Technologies, Inc.
1-702910C
In Commercial Distribution

  • 00190776380397 ()


  • Fixed-diameter cervical dilator, reusable
HEGAR DILATOR DOUBLE END 11" 7mm/8mm
Avalign Technologies, Inc.
1-70278C
In Commercial Distribution

  • 00190776380380 ()


  • Fixed-diameter cervical dilator, reusable
Breisky Vaginal Retractor 100x30mm, 11 1/2"
Avalign Technologies, Inc.
85-31032393
In Commercial Distribution

  • 00190776378431 ()


  • Hand-held surgical retractor, reusable
SIMS UTER CUR #00 SHARP MALLEABLE 11"
Avalign Technologies, Inc.
1-754-00M
In Commercial Distribution

  • 00190776307479 ()


  • Intrauterine curette, manual
DAFILON BLACK 11/0 (0.1) 8CM HRM4
B BRAUN SURGICAL SA
G1118374
Not in Commercial Distribution

  • 04038653748679 ()
  • 04046963059002 ()

  • Length: 8.0 Centimeter
  • Thread Material : polyamide
  • Size of Thread (USP - Others) : 11/0
G1118374

  • Nylon suture, non-bioabsorbable, monofilament
DAFILON BLACK 11/0 (0.1) 10CM DRM3
B BRAUN SURGICAL SA
G1118366
Not in Commercial Distribution

  • 04038653748655 ()
  • 04045439030194 ()

  • Thread Material : polyamide
  • Size of Thread (USP - Others) : 11/0
  • Length: 10.0 Centimeter
G1118366

  • Nylon suture, non-bioabsorbable, monofilament
DAFILON BLACK 11/0 (0.1) 10CM DRM4
B BRAUN SURGICAL SA
G1118080
Not in Commercial Distribution

  • 04038653748273 ()
  • 04045439057580 ()

  • Length: 10.00 Centimeter
  • Size of Thread (USP - Others) : 11/0
  • Thread Material : polyamide
G1118080

  • Nylon suture, non-bioabsorbable, monofilament
DAFILON BLACK 11/0 (0.1) 5CM DRM3
B BRAUN SURGICAL SA
G1118064
Not in Commercial Distribution

  • 04038653748235 ()
  • 04045439030088 ()

  • Size of Thread (USP - Others) : 11/0
  • Thread Material : polyamide
  • Length: 5.00 Centimeter
G1118064

  • Nylon suture, non-bioabsorbable, monofilament
DAFILON BLACK 11/0 (0.1) 30CM 2XDLM6
B BRAUN SURGICAL SA
G1111213
Not in Commercial Distribution

  • 04038653747719 ()
  • 04045439069934 ()

  • Size of Thread (USP - Others) : 11/0
  • Thread Material : polyamide
  • Length: 30.0 Centimeter
G1111213

  • Nylon suture, non-bioabsorbable, monofilament
DAFILON BLACK 11/0 (0.1) 15CM DLM4
B BRAUN SURGICAL SA
G1110012
Not in Commercial Distribution

  • 04038653747535 ()
  • 04045439057559 ()

  • Thread Material : polyamide
  • Size of Thread (USP - Others) : 11/0
  • Length: 15.00 Centimeter
G1110012

  • Nylon suture, non-bioabsorbable, monofilament
PS Notch Cutting Adaptor #11 (Saw Capture)
Corentec Co., Ltd
KA.CFC.BS11
In Commercial Distribution

  • 08800068962935 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Distal Centralizer, Progeny Cemented Stem, Size 11
GLOBUS MEDICAL, INC.
SC2077-11
In Commercial Distribution

  • 10840843103899 ()


  • Femoral stem centralizer
Snowden-Pencer ENDOPLASTIC DISSECTOR 5, 11 inches 28CM
STERIS CORPORATION
88-5075
In Commercial Distribution

  • 10885403153068 ()
885075

  • Open-surgery dissector
ENCINA TAPER STEM STANDARD OFFSET, SZ 11
STINSON ORTHOPEDICS INC.
110-00-011
In Commercial Distribution

  • 00841176101517 ()
110-00-011

  • Coated hip femur prosthesis, modular
LR CUS Torque -11, Tip +5 W
TP ORTHODONTICS INC
296-6882
In Commercial Distribution

  • 00192029051085 ()


  • Orthodontic bracket, metal
LL CUS Torque -11, Tip +5 W
TP ORTHODONTICS INC
296-6872
In Commercial Distribution

  • 00192029051078 ()


  • Orthodontic bracket, metal
UR CUS Torque -4, Tip +11 W
TP ORTHODONTICS INC
296-6802
In Commercial Distribution

  • 00192029051047 ()


  • Orthodontic bracket, metal
UL CUS Torque -4, Tip +11 W
TP ORTHODONTICS INC
296-6792
In Commercial Distribution

  • 00192029051030 ()


  • Orthodontic bracket, metal
ECHELON 190MM STRAIGHT STEM TRIAL SIZE 11
Smith & Nephew, Inc.
71368011
In Commercial Distribution

  • 03596010329530 ()
71368011

  • Femoral stem prosthesis trial
ECHELON 190MM POROUS FEMORAL COMPONENT SIZE 11
Smith & Nephew, Inc.
71340111
In Commercial Distribution

  • 03596010328700 ()
71340111

  • Coated hip femur prosthesis, modular
Trial 3.5mm Interlock Recon Plate, 11 H
Acumed LLC
71-0449
In Commercial Distribution

  • 10806378088490 ()


  • Orthopaedic fixation plate, non-bioabsorbable
Wangensteen Needle Holder, TC, straight, 28cm/11"
Anmuth Medical International, LLC
30-260-27TC
In Commercial Distribution

  • 08403207005380 ()

  • Length: 11 Inch
30-260-27TC

  • Suturing needle holder, reusable
HEANEY SIMON Retractor 1.25"x4.5" 28cm/11"
Anmuth Medical International, LLC
24-480-27
In Commercial Distribution

  • 08403207003577 ()

  • Length: 11 Inch
24-480-27

  • Hand-held surgical retractor, reusable
ROOT PICK DAVIS 11 LEFT, 189 H
NORDENT MANUFACTURING INC
ER11P/L
In Commercial Distribution

  • 00840018643505 ()


  • Dental elevator, tooth/root
RT PK DE DAVIS #11 STD HDL
NORDENT MANUFACTURING INC
ER11
In Commercial Distribution

  • 00840018643383 ()


  • Dental elevator, tooth/root
ROOT PICK, DAVIS 11, DL CR HAN
NORDENT MANUFACTURING INC
CEER11
In Commercial Distribution

  • 00840018643307 ()


  • Dental elevator, tooth/root
SYNERGY TITANIUM PRESSFIT FEMORAL COMPONENT SIZE 11
Smith & Nephew, Inc.
71306811
In Commercial Distribution

  • 03596010194657 ()
71306811

  • Ceramic femoral head prosthesis
SYNERGY HA PRESSFIT FEMORAL COMPONENT SIZE 11
Smith & Nephew, Inc.
71306711
In Commercial Distribution

  • 03596010194558 ()
71306711

  • Ceramic femoral head prosthesis
11 HOLE LONG PLATE - SMALL BONE FIXATOR
Smith & Nephew, Inc.
100418
In Commercial Distribution

  • 03596010029515 ()
100418

  • External orthopaedic fixation system, single-use
Origin Stem, Standard Offset Size 11 Collared
PAXEON RECONSTRUCTION LLC
PR111-18-1102
In Commercial Distribution

  • 08177570200443 ()


  • Coated hip femur prosthesis, modular
2.3 mm x 11 mm Hexalobe MultiScrew
Acumed LLC
3004-23011-S
In Commercial Distribution

  • 10806378022302 ()


  • Orthopaedic bone screw (non-sliding)
2.3 mm x 11 mm Hexalobe MultiScrew
Acumed LLC
3004-23011
In Commercial Distribution

  • 10806378022296 ()


  • Orthopaedic bone screw (non-sliding)
1.5 mm x 11 mm Hexalobe MultiScrew
Acumed LLC
3004-15011-S
In Commercial Distribution

  • 10806378021923 ()


  • Orthopaedic bone screw (non-sliding)
1.5 mm x 11 mm Hexalobe MultiScrew
Acumed LLC
3004-15011
In Commercial Distribution

  • 10806378021916 ()


  • Orthopaedic bone screw (non-sliding)
U4&5L .022 -11/+2/0 STD
ORMCO CORPORATION
497-6491
In Commercial Distribution

  • 00889989000481 ()
  • 10889989000488 ()

  • Slot Width: .022 Inch


  • Orthodontic bracket, ceramic
U4&5R .022 -11/+2/0 STD
ORMCO CORPORATION
497-6490
In Commercial Distribution

  • 00889989000474 ()
  • 10889989000471 ()

  • Slot Width: .022 Inch


  • Orthodontic bracket, ceramic
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