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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Twisted Gingival Retraction Cord with Epinephrine, 72 inches, Size: 9/1
PASCAL COMPANY, INC.
07710
In Commercial Distribution

  • 00310866000541 ()
07710

  • Gingival retraction cord, medicated
Twisted Gingival Retraction cord with Aluminum Sulfate, 72 inches, Size: 9/1
PASCAL COMPANY, INC.
07610
In Commercial Distribution

  • 00310866000503 ()
07610

  • Gingival retraction cord, non-medicated
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-59-0009
In Commercial Distribution

  • 09348215134600 ()


  • Coated hip femur prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-591-009
In Commercial Distribution

  • 09348215134860 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-59-0109
In Commercial Distribution

  • 09348215134730 ()


  • Coated hip femur prosthesis, modular
No Description
Bird & Cronin, LLC
08143009
Not in Commercial Distribution

  • 00610570175758 ()
  • 00610570011414 ()


  • Freestanding headrest, single-use
No Description
Bird & Cronin, LLC
PC0372
In Commercial Distribution

  • 00610570117123 ()


  • Abdominal binder, single-use
No Description
Bird & Cronin, LLC
PC0362
In Commercial Distribution

  • 00610570116584 ()


  • Abdominal binder, single-use
No Description
Bird & Cronin, LLC
PC0345
In Commercial Distribution

  • 00610570116577 ()


  • Abdominal binder, single-use
No Description
Bird & Cronin, LLC
50000372
In Commercial Distribution

  • 00610570111381 ()


  • Abdominal binder, single-use
No Description
Bird & Cronin, LLC
50000362
In Commercial Distribution

  • 00610570111374 ()


  • Abdominal binder, single-use
No Description
Bird & Cronin, LLC
M0372
In Commercial Distribution

  • 00610570093700 ()


  • Abdominal binder, single-use
No Description
Bird & Cronin, LLC
M0362
In Commercial Distribution

  • 00610570093557 ()


  • Abdominal binder, single-use
No Description
Bird & Cronin, LLC
M0345
In Commercial Distribution

  • 00610570093540 ()


  • Abdominal binder, single-use
No Description
Bird & Cronin, LLC
08145725
In Commercial Distribution

  • 00610570019489 ()


  • Wrist immobilizer, single-use
No Description
Bird & Cronin, LLC
08145724
In Commercial Distribution

  • 00610570019472 ()


  • Wrist immobilizer, single-use
No Description
Bird & Cronin, LLC
08145723
In Commercial Distribution

  • 00610570019465 ()


  • Wrist immobilizer, single-use
No Description
Bird & Cronin, LLC
08145722
In Commercial Distribution

  • 00610570019458 ()


  • Wrist immobilizer, single-use
No Description
Bird & Cronin, LLC
08145721
In Commercial Distribution

  • 00610570019441 ()


  • Wrist immobilizer, single-use
No Description
Bird & Cronin, LLC
08145715
In Commercial Distribution

  • 00610570019427 ()


  • Wrist immobilizer, single-use
No Description
Bird & Cronin, LLC
08145714
In Commercial Distribution

  • 00610570019410 ()


  • Wrist immobilizer, single-use
No Description
Bird & Cronin, LLC
08145713
In Commercial Distribution

  • 00610570019403 ()


  • Wrist immobilizer, single-use
No Description
Bird & Cronin, LLC
08145712
In Commercial Distribution

  • 00610570019397 ()


  • Wrist immobilizer, single-use
No Description
Bird & Cronin, LLC
08145711
Not in Commercial Distribution

  • 00610570019380 ()


  • Wrist immobilizer, single-use
Extra-large
DARCO INTERNATIONAL, INC.
232-0010-60
In Commercial Distribution

  • 10609271051383 ()
  • 00609271051386 ()
  • 20609271051380 ()
232-0010-60

  • Lumbar spine orthosis
Large
DARCO INTERNATIONAL, INC.
232-0010-50
In Commercial Distribution

  • 20609271051373 ()
  • 00609271051379 ()
  • 10609271051376 ()
232-0010-50

  • Lumbar spine orthosis
Medium
DARCO INTERNATIONAL, INC.
232-0010-40
In Commercial Distribution

  • 20609271051359 ()
  • 00609271051355 ()
  • 10609271051352 ()
232-0010-40

  • Lumbar spine orthosis
Small
DARCO INTERNATIONAL, INC.
232-0010-30
In Commercial Distribution

  • 10609271051338 ()
  • 00609271051331 ()
  • 20609271051335 ()
232-0010-30

  • Lumbar spine orthosis
No Description
SIZEWISE RENTALS, L.L.C.
PANACEA CONVERTIBLE 9 CELL MATTRESS
In Commercial Distribution

  • 00845699007998 ()


  • Alternating-pressure bed mattress
LEE NO. 9 DISSECTOR, DOUBLE-ENDED, SHORT AND LONG 1.0 MM PADDLES
Grace Medical, Inc.
6.80.09
In Commercial Distribution

  • 00844505012225 ()


  • Open-surgery dissector
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-16-0337
In Commercial Distribution

  • 09348215046361 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-201-609
In Commercial Distribution

  • 09348215056209 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-34-1009
In Commercial Distribution

  • 09348215056070 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-159
In Commercial Distribution

  • 09348215055882 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0908
In Commercial Distribution

  • 09348215055691 ()


  • Orthopaedic broach
Conformity stem, high offset, #9
UNITED ORTHOPEDIC CORP.
1110-3209
In Commercial Distribution

  • 04711605583367 ()
1110-3209

  • Metal-on-polyethylene total hip prosthesis
  • Revision coated hip femur prosthesis
  • Coated hip femur prosthesis, modular
No Description
W.H. Holden, Inc.
210-230-101
In Commercial Distribution

  • D9282102301010 ()


  • Dental rongeur
No Description
W.H. Holden, Inc.
10-5188L
In Commercial Distribution

  • D928105188L0 ()


  • Bone curette, reusable
No Description
W.H. Holden, Inc.
10-5187L
In Commercial Distribution

  • D928105187L0 ()


  • Bone curette, reusable
No Description
W.H. Holden, Inc.
10-5186L
In Commercial Distribution

  • D928105186L0 ()


  • Bone curette, reusable
No Description
W.H. Holden, Inc.
10-5185L
In Commercial Distribution

  • D928105185L0 ()


  • Bone curette, reusable
No Description
W.H. Holden, Inc.
10-5184L
In Commercial Distribution

  • D928105184L0 ()


  • Bone curette, reusable
No Description
W.H. Holden, Inc.
10-5183L
In Commercial Distribution

  • D928105183L0 ()


  • Bone curette, reusable
No Description
W.H. Holden, Inc.
10-5182L
In Commercial Distribution

  • D928105182L0 ()


  • Bone curette, reusable
No Description
W.H. Holden, Inc.
10-5181L
In Commercial Distribution

  • D928105181L0 ()


  • Bone curette, reusable
No Description
W.H. Holden, Inc.
10-5180L
In Commercial Distribution

  • D928105180L0 ()


  • Bone curette, reusable
No Description
W.H. Holden, Inc.
10-5409-3-2E
In Commercial Distribution

  • D92810540932E0 ()


  • Periosteal elevator, reusable
No Description
Silipos Holding LLC
90565
In Commercial Distribution

  • 00614464905650 ()


  • Custom-made cushion
No Description
JOINT RESTORATION FOUNDATION INC
1
In Commercial Distribution

  • 00860424000280 ()
PSP-091

  • Tendon graft
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
0407-100
In Commercial Distribution

  • 00848665032338 ()


  • Surgical screwdriver, reusable
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