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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JMU M3.0g Nitrile Examination Gloves, Size XS, Powder-Free, Non-Sterile, Black, 200pcs/box
JMU DENTAL, INC
25301023
In Commercial Distribution

  • D930253010230 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
IOS external fixator system (Long)
METAPHYSIS LLP
2-0-0L
In Commercial Distribution

  • 05060309872000 ()


  • External orthopaedic fixation system, single-use
Blizzard Compact Trauma Blanket
BLIZZARD PROTECTION SYSTEMS LIMITED
BPS2-37O
In Commercial Distribution

  • 05060297210181 ()
BPS2-37O

  • Hypothermia-prevention whole-body suit
Blizzard Trauma Blanket with Hook & Loop Closure
BLIZZARD PROTECTION SYSTEMS LIMITED
BPS-44(VB)
In Commercial Distribution

  • 05060297210150 ()
BPS-44(VB)

  • Hypothermia-prevention whole-body suit
Blizzard Trauma Blanket with Hook & Loop Closure - 3 layer orange trauma blanket
BLIZZARD PROTECTION SYSTEMS LIMITED
BPS-44(FP)
In Commercial Distribution

  • 05060297210143 ()
BPS-44(FP)

  • Hypothermia-prevention whole-body suit
Blizzard Casualty Trauma Blanket - SPR Blanket - 3 layer orange casualty trauma blanket
BLIZZARD PROTECTION SYSTEMS LIMITED
BSPR-03
In Commercial Distribution

  • 05060297210112 ()
BSPR-03

  • Hypothermia-prevention whole-body suit
Blizzard Casualty Trauma Blanket - green casualty trauma blanket
BLIZZARD PROTECTION SYSTEMS LIMITED
BSPR-01
In Commercial Distribution

  • 05060297210105 ()
BSPR-01

  • Hypothermia-prevention whole-body suit
Blizzard Casualty Trauma Blanket XL - 3 layer orange XL blanket
BLIZZARD PROTECTION SYSTEMS LIMITED
BH-09
In Commercial Distribution

  • 05060297210099 ()
BH-09

  • Hypothermia-prevention whole-body suit
Blizzard Casualty Trauma Blanket XL - Green
BLIZZARD PROTECTION SYSTEMS LIMITED
BH-07
In Commercial Distribution

  • 05060297210082 ()
BH-07

  • Hypothermia-prevention whole-body suit
Blizzard AMB Trauma Blanket - 3 layer orange full length blanket with side access to arms with hook and loop closure.
BLIZZARD PROTECTION SYSTEMS LIMITED
BPS-34
In Commercial Distribution

  • 05060297210051 ()
BPS-34

  • Hypothermia-prevention whole-body suit
Blizzard AMB Trauma Blanket - 3 layer green full length blanket with side access to arms with hook and loop closure.
BLIZZARD PROTECTION SYSTEMS LIMITED
BPS-33
In Commercial Distribution

  • 05060297210020 ()
BPS-33

  • Hypothermia-prevention whole-body suit
Blizzard Trauma Blanket - 3-layer Orange Trauma Blanket
BLIZZARD PROTECTION SYSTEMS LIMITED
BPS-10
In Commercial Distribution

  • 05060297210013 ()
BPS-10

  • Hypothermia-prevention whole-body suit
Blizzard Trauma Blanket
BLIZZARD PROTECTION SYSTEMS LIMITED
BPS-01
In Commercial Distribution

  • 05060297210006 ()
BPS-01

  • Hypothermia-prevention whole-body suit
Osteotome
Stanmore Implants Worldwide Ltd
imostme/15
Not in Commercial Distribution

  • 05060296233754 ()
IMOSTME-15

  • Orthopaedic osteotome
Offset Blade Left, Size 18 X 40 mm
K2M, INC.
SP-4037-08
In Commercial Distribution

  • 10888857462908 ()

  • Width: 18 Millimeter
  • Length: 40 Millimeter
SP-4037-08

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Offset Blade Left, Size 18 X 30 mm
K2M, INC.
SP-4037-07
In Commercial Distribution

  • 10888857462892 ()

  • Length: 30 Millimeter
  • Width: 18 Millimeter
SP-4037-07

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Offset Blade Right, Size 18 X 40 mm
K2M, INC.
SP-4037-06
In Commercial Distribution

  • 10888857462885 ()

  • Length: 40 Millimeter
  • Width: 18 Millimeter
SP-4037-06

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Offset Blade Right, Size 18 X 30 mm
K2M, INC.
SP-4037-05
In Commercial Distribution

  • 10888857462878 ()

  • Width: 18 Millimeter
  • Length: 30 Millimeter
SP-4037-05

  • Orthopaedic prosthesis implantation positioning instrument, reusable
ACDF M/L Retractor Blade, Size 16 X 45 mm
K2M, INC.
SP-4037-04
In Commercial Distribution

  • 10888857462861 ()

  • Length: 45 Millimeter
  • Width: 16 Millimeter
SP-4037-04

  • Orthopaedic prosthesis implantation positioning instrument, reusable
BONE CHISELS C9
Power Dental U.S.A. Inc.
4215
In Commercial Distribution

  • D9434215 ()
4215

  • Orthopaedic chisel
ACDF C-C Blade, Size 18 X 40 mm
K2M, INC.
SP-4037-02
In Commercial Distribution

  • 10888857462847 ()

  • Length: 40 Millimeter
  • Width: 18 Millimeter
SP-4037-02

  • Orthopaedic prosthesis implantation positioning instrument, reusable
BONE CHISELS C7
Power Dental U.S.A. Inc.
4213
In Commercial Distribution

  • D94342130 ()
4213

  • Orthopaedic chisel
BONE CHISELS W1
Power Dental U.S.A. Inc.
4210
In Commercial Distribution

  • D9434210 ()
4210

  • Orthopaedic chisel
BONE CHISELS C4
Power Dental U.S.A. Inc.
4209
In Commercial Distribution

  • D9434209 ()
4209

  • Orthopaedic chisel
BONE CHISELS GAR1
Power Dental U.S.A. Inc.
4201
In Commercial Distribution

  • D9434201 ()
4201

  • Orthopaedic chisel
X SERRATED CURETTE PREMIUM BLACK EDITION KIT ..EASY REMOVE GRANULATION TISSUE SET OF 4
Power Dental U.S.A. Inc.
4126E
In Commercial Distribution

  • D9434126E00 ()
4126E

  • Dental elevator, tooth/root
  • Periosteal elevator, reusable
Power Curettes Serrated Kit..POWER CURETTES SET SERRATED TIPS (5PCS)
Power Dental U.S.A. Inc.
4126
In Commercial Distribution

  • D94341260 ()
4126

  • Dental elevator, tooth/root
  • Periosteal elevator, reusable
POWER FLEX LUXATOR CVD 4.5mm ± 5 % TITANIUM
Power Dental U.S.A. Inc.
4035-6
In Commercial Distribution

  • D943403560 ()
4035-6

  • Dental elevator, tooth/root
POWER FLEX LUXATOR STR 4.5mm ± 5 % TITANIUM
Power Dental U.S.A. Inc.
4035-5
In Commercial Distribution

  • D943403550 ()
4035-5

  • Dental elevator, tooth/root
POWER FLEX LUXATOR CVD 3.5mm ± 5 % TITANIUM
Power Dental U.S.A. Inc.
4035-4
In Commercial Distribution

  • D943403540 ()
4035-4

  • Dental elevator, tooth/root
POWER FLEX LUXATOR STR 3.5mm ± 5 % TITANIUM
Power Dental U.S.A. Inc.
4035-3
In Commercial Distribution

  • D943403530 ()
4035-3

  • Dental elevator, tooth/root
POWER FLEX LUXATOR CVD 2.5mm ± 5 % TITANIUM
Power Dental U.S.A. Inc.
4035-2
In Commercial Distribution

  • D943403520 ()
4035-2

  • Dental elevator, tooth/root
POWER FLEX LUXATOR STR 2.5mm ± 5 % TITANIUM
Power Dental U.S.A. Inc.
4035-1
In Commercial Distribution

  • D943403510 ()
4035-1

  • Dental elevator, tooth/root
X POWER FLEX LUXATION TITANIUM SET OF 6, Patent No. USD700331S USD700329S
Power Dental U.S.A. Inc.
4035
In Commercial Distribution

  • D94340350 ()
4035

  • Dental elevator, tooth/root
POWER FLEX E77 UP 4.0mm ± 5 % TITANIUM
Power Dental U.S.A. Inc.
4034-5
In Commercial Distribution

  • D943403450 ()
4034-5

  • Dental elevator, tooth/root
POWER FLEX SELDIN 34S 4.0mm ± 5 % TITANIUM
Power Dental U.S.A. Inc.
4034-4
In Commercial Distribution

  • D943403440 ()
4034-4

  • Dental elevator, tooth/root
POWER FLEX APEXO 301 STR 2.8mm ± 5 % TITANIUM
Power Dental U.S.A. Inc.
4034-1
In Commercial Distribution

  • D943403410 ()
4034-1

  • Dental elevator, tooth/root
ASDF
Power Dental U.S.A. Inc.
1299
Not in Commercial Distribution

  • D9434027N00 ()
1299

  • Dressing/utility forceps, scissors-like, reusable
  • Bone graft syringe, single-use
Port Shim Size Ø26 mm
K2M, INC.
AN01-90028
In Commercial Distribution

  • 10888857462335 ()

  • Outer Diameter: 26 Millimeter
AN01-90028

  • Surgical retractor/retraction system blade, reusable
Port Shim Size Ø26 mm
K2M, INC.
AN01-90027
In Commercial Distribution

  • 10888857462328 ()

  • Outer Diameter: 24 Millimeter
AN01-90027

  • Surgical retractor/retraction system blade, reusable
Port Shim Size Ø22 mm
K2M, INC.
AN01-90026
In Commercial Distribution

  • 10888857462311 ()

  • Outer Diameter: 22 Millimeter
AN01-90026

  • Surgical retractor/retraction system blade, reusable
ASDF
Power Dental U.S.A. Inc.
1298
Not in Commercial Distribution

  • D9434026N00 ()
1298

  • Bone graft syringe, single-use
  • Dressing/utility forceps, scissors-like, reusable
Port Shim Size Ø18 mm
K2M, INC.
AN01-90024
In Commercial Distribution

  • 10888857462298 ()

  • Outer Diameter: 18 Millimeter
AN01-90024

  • Surgical retractor/retraction system blade, reusable
ASDF
Power Dental U.S.A. Inc.
1297
Not in Commercial Distribution

  • D9434024N00 ()
1297

  • Dressing/utility forceps, scissors-like, reusable
  • Bone graft syringe, single-use
Port Shim Size Ø 14 mm
K2M, INC.
AN01-90022
In Commercial Distribution

  • 10888857462274 ()

  • Outer Diameter: 14 Millimeter
AN01-90022

  • Surgical retractor/retraction system blade, reusable
ASDF
Power Dental U.S.A. Inc.
1296
Not in Commercial Distribution

  • D9434023N00 ()
1296

  • Dressing/utility forceps, scissors-like, reusable
  • Bone graft syringe, single-use
POWER TWIST ELEVATOR HEAVY DUTY STR -L Patent No. USD700331S USD700329S
Power Dental U.S.A. Inc.
4023
In Commercial Distribution

  • D9434023 ()
4023

  • Dental elevator, tooth/root
POWER TWIST ROOT TIP PICKS 2mm ROOT STR-R TITANIUM Patent No. USD700331S USD700329S
Power Dental U.S.A. Inc.
3895S
In Commercial Distribution

  • D9433895S00 ()
3895S

  • Dental elevator, tooth/root
  • Periotome, reusable
POWER TWIST PERIOTOME 4mm ANTERIOR, STR-R TITANIUM Patent No. USD700331S USD700329S
Power Dental U.S.A. Inc.
3895G
In Commercial Distribution

  • D9433895G0 ()
3895G

  • Dental elevator, tooth/root
  • Periotome, reusable
Widening Shim, (R)
K2M, INC.
AC01-90053
In Commercial Distribution

  • 10888857461390 ()
AC01-90053

  • Surgical retractor/retraction system blade, reusable
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