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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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Power Dental U.S.A., Inc. - D943N1320

SCALERS/CURETTES MC7/9
Power Dental U.S.A. Inc.
N1320
Not in Commercial Distribution

  • D943N1320 ()
N1320

  • Manual dental scaler, reusable

Power Dental USA - D9439030SLEK00

EXTRACTION KIT-2 (9 PCS)
Power Dental U.S.A. Inc.
9030-SLEK
In Commercial Distribution

  • D9439030SLEK00 ()
9030-SLEK

  • Tooth extraction forceps

Aleutian Interbody System - 10888857413153

Modular Trial Size 9
K2M, INC.
SP-3099-03
Not in Commercial Distribution

  • 10888857413153 ()
SP-3099-03

  • General internal orthopaedic fixation system implantation kit

Medtronic Reusable Instruments - 00643169225947

REAMER EX0712075 SIZE 9
MEDTRONIC SOFAMOR DANEK, INC.
EX0712075
In Commercial Distribution

  • 00643169225947 ()


  • Orthopaedic broach

N/A - 00643169236721

DRIVER 7480687 HEX 9
MEDTRONIC SOFAMOR DANEK, INC.
7480687
In Commercial Distribution

  • 00643169236721 ()


  • Surgical screwdriver, reusable

Power Dental U.S.A., Inc. - D943N7257

RUBBER DAM CLAMPS 9
Power Dental U.S.A. Inc.
N7257
In Commercial Distribution

  • D943N7257 ()
N7257

  • Rubber dam clamp

CHESAPEAKE Stabilization System - 10888857297234

Distractor Size 9 mm
K2M, INC.
SP-1566-02
In Commercial Distribution

  • 10888857297234 ()

  • Height: 9 Millimeter
SP-1566-02

  • Orthopaedic prosthesis implantation positioning instrument, reusable

United Hip System - 04711605583640

Conformity stem, cemented, #9
UNITED ORTHOPEDIC CORP.
1110-7009
In Commercial Distribution

  • 04711605583640 ()
1110-7001

  • Metal-on-polyethylene total hip prosthesis

SCANLAN® Suction System Devices - 00846159011630

9 Fr Suction Tip
SCANLAN INTERNATIONAL INC
9009-987
In Commercial Distribution

  • 00846159011630 ()
9009-987

  • Surgical/emergency suction cannula, non-illuminating, reusable

SCANLAN® Suction System Devices - 00846159011555

9 Fr Suction Tip
SCANLAN INTERNATIONAL INC
9009-967
In Commercial Distribution

  • 00846159011555 ()
9009-967

  • Surgical/emergency suction cannula, non-illuminating, reusable

SCANLAN® Suction System Devices - 00846159011470

9 Fr Suction Tip
SCANLAN INTERNATIONAL INC
9009-947
In Commercial Distribution

  • 00846159011470 ()
9009-947

  • Surgical/emergency suction cannula, non-illuminating, reusable

U2 Total Knee System - 04719872142102

Gap gauge, 9/11mm
UNITED ORTHOPEDIC CORP.
9404-7009-RA
In Commercial Distribution

  • 04719872142102 ()


  • Surgical implant template, reusable

OsteoMed - 00845694035873

.062 x 9 K-wire
OSTEOMED LLC
316-0121
In Commercial Distribution

  • 00845694035873 ()

  • Outer Diameter: 0.062 Inch
316-0121

  • General internal orthopaedic fixation system implantation kit

SCANLAN® Suction System Devices - 00846159021431

9 Fr Suction Tip
SCANLAN INTERNATIONAL INC
9009-975
In Commercial Distribution

  • 00846159021431 ()
9009-975

  • Surgical/emergency suction cannula, non-illuminating, reusable

SCANLAN® Suction System Devices - 00846159021370

9 Fr Suction Tip
SCANLAN INTERNATIONAL INC
9009-957
In Commercial Distribution

  • 00846159021370 ()
9009-957

  • Surgical/emergency suction cannula, non-illuminating, reusable

SCANLAN® Suction System Devices - 00846159021516

9 Fr Suction Tip
SCANLAN INTERNATIONAL INC
9009-997
In Commercial Distribution

  • 00846159021516 ()
9009-997

  • Surgical/emergency suction cannula, non-illuminating, reusable

UTF™ Stem - 04719872167525

UTF Broach, reduced, #9
UNITED ORTHOPEDIC CORP.
9106-6309
In Commercial Distribution

  • 04719872167525 ()

  • reduced, #9
9106-6309

  • Orthopaedic broach

NA - 04546540401083

FLUOROSCOPY TRACKER KIT, 9''
Stryker Leibinger GmbH & Co. KG
6004-509-000
In Commercial Distribution

  • 04546540401083 ()

  • Diameter: 9.0 Inch
6004-509-000

  • Multi-purpose stereotactic surgery system

Belun Ring - 04899959015038

Belun Ring Size 9
Belun Technology Company Limited
BLR-100C
Not in Commercial Distribution

  • 04899959015038 ()


  • Pulse oximeter

U2™ Knee - 04719872177531

Gap gauge, 9/11mm
UNITED ORTHOPEDIC CORP.
9404-7009
In Commercial Distribution

  • 04719872177531 ()

  • 9/11mm
9404-7009

  • Surgical implant template, reusable

ASPECT Anterior Cervical Plate System - 00846468061937

FIXED GUIDE, DTS, 9°
Pioneer Surgical Technology, Inc.
27-FX-GUIDE-DTS-9
Not in Commercial Distribution

  • 00846468061937 ()
27-FX-GUIDE-DTS-9

  • Orthopaedic implantation sleeve, reusable

Power Dental USA - D9432101

HATCHETS H8/9 [10-7-14]
Power Dental U.S.A. Inc.
2101
In Commercial Distribution

  • D9432101 ()
2101

  • Dressing/utility forceps, scissors-like, reusable
  • Periodontal hoe

Power Dental USA - D9433512S0

PERIOSTEALS HOWARD 9 MINI
Power Dental U.S.A. Inc.
3512S
In Commercial Distribution

  • D9433512S0 ()
3512S

  • Dental elevator, tooth/root
  • Periosteal elevator, reusable

ALEUTIAN® Interbody Systems - 10888857494220

Osteotome, Size 9 mm
K2M, INC.
SP-4232-02
In Commercial Distribution

  • 10888857494220 ()

  • Width: 9 Millimeter
SP-4232-02

  • Orthopaedic prosthesis implantation positioning instrument, reusable

ALEUTIAN® Interbody Systems - 10888857487130

Spreader, Size 9 mm
K2M, INC.
SP-4210-03
In Commercial Distribution

  • 10888857487130 ()

  • Height: 9 Millimeter
SP-4210-03

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Luna - 00643293031629

Luna Right Size 9
TRULIFE LIMITED
622 09R
In Commercial Distribution

  • 00643293031629 ()


  • External breast prosthesis

Luna - 00643293031520

Luna Left Size 9
TRULIFE LIMITED
622 09L
In Commercial Distribution

  • 00643293031520 ()


  • External breast prosthesis

Symphony - 00643293013465

Symphony Cover Size 9
TRULIFE LIMITED
C633 09
In Commercial Distribution

  • 00643293013465 ()


  • External breast prosthesis

Triangular Partial - 00643293006412

Triangular Partial Size 9
TRULIFE LIMITED
533 09
In Commercial Distribution

  • 00643293006412 ()


  • External breast prosthesis

Tri-Leisure Form - 00643293005811

Tri-Leisure Form Size 9
TRULIFE LIMITED
611 09
In Commercial Distribution

  • 00643293005811 ()


  • External breast prosthesis
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