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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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SURGIPROS - 00810143902327

DE'BAKEY ATR.FCPS 2.0MM STR 9 1/2"
Surgipros, LLC
FB404SP
In Commercial Distribution

  • 00810143902327 ()


  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable

STRIPPER - 00888118064172

HARGIS, J SHAPE, LEFT, 9 MM TIP
KLS-Martin L.P.
38-837-04-07
In Commercial Distribution

  • 00888118064172 ()

  • 24 CM


  • Bone file/rasp, manual, reusable

STRIPPER - 00888118064158

HARGIS, J SHAPE, RIGHT, 9 MM TIP
KLS-Martin L.P.
38-837-02-07
In Commercial Distribution

  • 00888118064158 ()

  • 24 CM


  • Bone file/rasp, manual, reusable

Unitron - 07613389286731

D Stride P R 9 (pewter shine)
Unitron Hearing Division
050-6194-S5
In Commercial Distribution

  • 07613389286731 ()
050-6194-S5

  • Air-conduction hearing aid, behind-the-ear

Unitron - 07613389286724

D Stride P R 9 (espresso boost)
Unitron Hearing Division
050-6194-S3
In Commercial Distribution

  • 07613389286724 ()
050-6194-S3

  • Air-conduction hearing aid, behind-the-ear

Unitron - 07613389286717

D Stride P R 9 (amber suede)
Unitron Hearing Division
050-6194-S2
In Commercial Distribution

  • 07613389286717 ()
050-6194-S2

  • Air-conduction hearing aid, behind-the-ear

PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM - 07630031704870

Advanced Fixed Bar, 9 Implants, ZrO2/TAN
Institut Straumann AG
Bridges (implant borne)
Not in Commercial Distribution

  • 07630031704870 ()
010.7106

  • Dental implant suprastructure, permanent, preformed

PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM - 07630031704788

Basic Fixed Bar, 9 Implants, ZrO2/TAN
Institut Straumann AG
Bridges (implant borne)
Not in Commercial Distribution

  • 07630031704788 ()
010.7097

  • Dental implant suprastructure, permanent, preformed

PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM - 07630031704696

Advanced Fixed Bar, 9 Implants, Ti/TAN
Institut Straumann AG
Bridges (implant borne)
In Commercial Distribution

  • 07630031704696 ()
010.7088

  • Dental implant suprastructure, permanent, preformed

STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, DOLDER BAR TITANIUM - 07630031702302

CARES® Bar, 9 implants, Ti / TAN
Institut Straumann AG
Bars
In Commercial Distribution

  • 07630031702302 ()
010.1098

  • Dental implant suprastructure, permanent, preformed

iNSitu Total Hip System - 00816127029134

Femoral Stem, Size 9, Lateral, Taper Coated
NEXTSTEP ARTHROPEDIX, LLC
10-11-0009-TC
In Commercial Distribution

  • 00816127029134 ()


  • Coated femoral stem prosthesis, modular

iNSitu Total Hip System - 00816127028984

Femoral Stem, Size 9, Standard, Taper Coated
NEXTSTEP ARTHROPEDIX, LLC
10-10-0009-TC
In Commercial Distribution

  • 00816127028984 ()


  • Coated femoral stem prosthesis, modular

iNSitu™ Hip System - 00816127028557

Dual Tapered, Femoral Stem, Size 9, Lateral
NEXTSTEP ARTHROPEDIX, LLC
10-14-0009
In Commercial Distribution

  • 00816127028557 ()


  • Coated femoral stem prosthesis, modular

iNSitu™ Hip System - 00816127028373

Dual Tapered, Femoral Stem, Size 9, Standard
NEXTSTEP ARTHROPEDIX, LLC
10-13-0009
In Commercial Distribution

  • 00816127028373 ()


  • Coated femoral stem prosthesis, modular

iNSitu™ Hip System - 00816127028168

Neck Trial, Size 9, Lateral, Dual Taper
NEXTSTEP ARTHROPEDIX, LLC
10-81-0409
In Commercial Distribution

  • 00816127028168 ()


  • Femoral stem prosthesis trial

iNSitu™ Hip System - 00816127027956

Neck Trial, Size 9, Standard, Dual Taper
NEXTSTEP ARTHROPEDIX, LLC
10-81-0309
In Commercial Distribution

  • 00816127027956 ()


  • Femoral stem prosthesis trial

TheRay Collared and Collarless Femoral Stem - 00816127026461

NECK TRIAL, COLLARED STEM, LATERAL, SIZE 9
NEXTSTEP ARTHROPEDIX, LLC
12-81-0109
In Commercial Distribution

  • 00816127026461 ()


  • Femoral stem prosthesis trial

TheRay Collared and Collarless Femoral Stem - 00816127026331

NECK TRIAL, COLLARED STEM, STANDARD, SIZE 9
NEXTSTEP ARTHROPEDIX, LLC
12-81-0009
In Commercial Distribution

  • 00816127026331 ()


  • Femoral stem prosthesis trial

TheRay Collared and Collarless Femoral Stem - 00816127025471

TheRay Collared Femoral Stem, Size 9, Lateralized
NEXTSTEP ARTHROPEDIX, LLC
12-11-0009
In Commercial Distribution

  • 00816127025471 ()


  • Coated femoral stem prosthesis, modular

TheRay Collared and Collarless Femoral Stem - 00816127025341

TheRay Collared Femoral Stem, Size 9, Standard
NEXTSTEP ARTHROPEDIX, LLC
12-10-0009
In Commercial Distribution

  • 00816127025341 ()


  • Coated femoral stem prosthesis, modular

BOSS Instruments - 00888515301610

Lambotte Osteotome, str, 9 3/4", 2"
BOSS INSTRUMENTS, LTD., INC.
70-3806
In Commercial Distribution

  • 00888515301610 ()
70-3806

  • Orthopaedic osteotome

Stealth Surgical - 00888515272446

SELLA PUNCH KERRISON, 40DEG UP, 9", 1MM
BOSS INSTRUMENTS, LTD., INC.
SS4061
In Commercial Distribution

  • 00888515272446 ()
SS4061

  • Spinal rongeur

Surgical Direct - B382SD9146531440

9 inch Hatt Spoon, 10mm Oval Cup
Surgical Direct, Inc.
SD914653144
In Commercial Distribution

  • B382SD9146531440 ()
SD914653144

  • Bone curette, reusable

Surgical Direct - B382SD9146531400

9 inch Hatt Spoon, 20mm Oval Cup
Surgical Direct, Inc.
SD914653140
In Commercial Distribution

  • B382SD9146531400 ()
SD914653140

  • Bone curette, reusable

Surgical Direct - B382SD9146531390

9 inch Hatt Spoon, 15mm Oval Cup
Surgical Direct, Inc.
SD914653139
In Commercial Distribution

  • B382SD9146531390 ()
SD914653139

  • Bone curette, reusable

Surgical Direct - B382SD9146343000

9 inch Bruns Curette, Straight, Size 3
Surgical Direct, Inc.
SD914634300
In Commercial Distribution

  • B382SD9146343000 ()
SD914634300

  • Bone curette, reusable

Surgical Direct - B382SD9146342000

9 inch Bruns Curette, Straight, Size 2
Surgical Direct, Inc.
SD914634200
In Commercial Distribution

  • B382SD9146342000 ()
SD914634200

  • Bone curette, reusable

Surgical Direct - B382SD9146341000

9 Inch Bruns Curette, Straight, Size 1
Surgical Direct, Inc.
SD914634100
In Commercial Distribution

  • B382SD9146341000 ()
SD914634100

  • Bone curette, reusable

Surgical Direct - B382SD9146340000

9 inch Bruns Curette, Straight, Size 0
Surgical Direct, Inc.
SD914634000
In Commercial Distribution

  • B382SD9146340000 ()
SD914634000

  • Bone curette, reusable

Arthrex® - 00888867214866

iBalance TKA, Tibial Prep Tray, Size 9
ARTHREX, INC.
AR-623-T9
In Commercial Distribution

  • 00888867214866 ()
AR-623-T9

  • Device sterilization/disinfection container, reusable

Surgical Direct - B382SD9146280100

9" Hibbs Spratt Bone Curette, Size 1
Surgical Direct, Inc.
SD914628010
In Commercial Distribution

  • B382SD9146280100 ()
SD914628010

  • Bone curette, reusable

Surgical Direct - B382SD9146270000

9" Spinal Fusion Curette, Straight, Size 00
Surgical Direct, Inc.
SD914627000
In Commercial Distribution

  • B382SD9146270000 ()
SD914627000

  • Callous file/rasp, reusable

Surgical Direct - B382SD9146151000

9 inch Spinal Fusion Curette, Size 000000
Surgical Direct, Inc.
SD914615100
In Commercial Distribution

  • B382SD9146151000 ()
SD914615100

  • Bone curette, reusable

Surgical Direct - B382SD9146141000

9" Spinal Curette, Rev. Angled, Size 00000
Surgical Direct, Inc.
SD914614100
In Commercial Distribution

  • B382SD9146141000 ()
SD914614100

  • Bone curette, reusable

Surgical Direct - B382SD914614100

9" Semmes Spinal Fusion Curette, Straight, 7mm
Surgical Direct, Inc.
SD91461410
In Commercial Distribution

  • B382SD914614100 ()
SD91461410

  • Bone curette, reusable

Surgical Direct - B382SD9144601020

8 inch Stille Chisel, 9/16 inch
Surgical Direct, Inc.
SD914460102
In Commercial Distribution

  • B382SD9144601020 ()
SD914460102

  • Orthopaedic osteotome

Surgical Direct - B382SD914457100

9 1/2" Hibbs Osteotome Curved, 10mm
Surgical Direct, Inc.
SD91445710
In Commercial Distribution

  • B382SD914457100 ()
SD91445710

  • Orthopaedic osteotome

Surgical Direct - B382SD914456260

9 1/2” Hibbs Osteotome, Straight, 16mm
Surgical Direct, Inc.
SD91445626
In Commercial Distribution

  • B382SD914456260 ()
SD91445626

  • Orthopaedic osteotome

Surgical Direct - B382SD914456250

9 1/2" Hibbs Osteotome, Straight 1"
Surgical Direct, Inc.
SD91445625
In Commercial Distribution

  • B382SD914456250 ()
SD91445625

  • Orthopaedic osteotome

Surgical Direct - B382SD914456220

9 1/2” Hibbs Osteotome, Straight, 12mm
Surgical Direct, Inc.
SD91445622
In Commercial Distribution

  • B382SD914456220 ()
SD91445622

  • Orthopaedic osteotome
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