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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Crile-Wood needle holder, 6'', straight, serrated TC jaws, gold ring handle
AMBLER SURGICAL CORP.
Crile-Wood needle holder
In Commercial Distribution

  • 00190660115272 ()
50-701

  • Suturing needle holder, reusable
Crile-Wood needle holder, 6'', straight, serrated jaws, ring handle
AMBLER SURGICAL CORP.
Crile-Wood needle holder
In Commercial Distribution

  • 00190660115258 ()
50-700

  • Suturing needle holder, reusable
Crile-Wood needle holder, 10'', straight, serrated TC jaws, gold ring handle
AMBLER SURGICAL CORP.
Crile-Wood needle holder
In Commercial Distribution

  • 00190660115203 ()
50-740

  • Suturing needle holder, reusable
Baumgartner needle holder, 5'', straight, serrated TC jaws, gold ring handle
AMBLER SURGICAL CORP.
Baumgartner needle holder
In Commercial Distribution

  • 00190660113735 ()
52-200

  • Suturing needle holder, reusable
O'Sullivan-O'Connor self-retaining vaginal speculum, complete set includes: frame, 2 lateral blades, and 3 center blades - 5/8'' x 1 3/4'', 1 1/2'' x 3 1/3'', and 1 3/4'' x 3 1/2''
AMBLER SURGICAL CORP.
O'Sullivan-O'Connor self-retaining vaginal speculum
In Commercial Distribution

  • 00190660180386 ()
186-565

  • Hand-held surgical retractor, reusable
Weitlaner self-retaining retractor, 6 1/2'', 3x4 sharp prongs, ring handle with ratchet catch
AMBLER SURGICAL CORP.
Weitlaner self-retaining retractor
In Commercial Distribution

  • 00190660144081 ()
73-615

  • Self-retaining surgical retractor, reusable
Weitlaner self-retaining retractor, 6 1/2'', 3x4 blunt prongs, ring handle with ratchet catch
AMBLER SURGICAL CORP.
Weitlaner self-retaining retractor
In Commercial Distribution

  • 00190660144067 ()
73-613

  • Self-retaining surgical retractor, reusable
Weitlaner self-retaining retractor, 5 1/2'', 3x4 sharp prongs, ring handle with ratchet catch
AMBLER SURGICAL CORP.
Weitlaner self-retaining retractor
In Commercial Distribution

  • 00190660144036 ()
73-606

  • Self-retaining surgical retractor, reusable
Weitlaner self-retaining retractor, 5 1/2'', 3x4 blunt prongs, ring handle with ratchet catch
AMBLER SURGICAL CORP.
Weitlaner self-retaining retractor
In Commercial Distribution

  • 00190660144012 ()
73-604

  • Self-retaining surgical retractor, reusable
Weitlaner self-retaining retractor, 4'', 2x3 sharp prongs, ring handle with ratchet catch
AMBLER SURGICAL CORP.
Weitlaner self-retaining retractor
In Commercial Distribution

  • 00190660143985 ()
73-602

  • Self-retaining surgical retractor, reusable
Weitlaner self-retaining retractor, 4'', 2x3 blunt prongs, ring handle with ratchet catch
AMBLER SURGICAL CORP.
Weitlaner self-retaining retractor
In Commercial Distribution

  • 00190660143954 ()
73-600

  • Self-retaining surgical retractor, reusable
Volkman retractor, 8 3/4'', USA pattern, 6 sharp prongs, 40.0mm wide, ring handle
AMBLER SURGICAL CORP.
Volkman retractor
In Commercial Distribution

  • 00190660143879 ()
73-573

  • Hand-held surgical retractor, reusable
Volkman retractor, 8 3/4'', USA pattern, 6 blunt prongs, 40.0mm wide, ring handle
AMBLER SURGICAL CORP.
Volkman retractor
In Commercial Distribution

  • 00190660143855 ()
73-563

  • Hand-held surgical retractor, reusable
Volkman retractor, 8 3/4'', USA pattern, 4 sharp prongs, 26.0mm wide, ring handle
AMBLER SURGICAL CORP.
Volkman retractor
In Commercial Distribution

  • 00190660143831 ()
73-572

  • Hand-held surgical retractor, reusable
Volkman retractor, 8 3/4'', USA pattern, 4 blunt prongs, 26.0mm wide, ring handle
AMBLER SURGICAL CORP.
Volkman retractor
In Commercial Distribution

  • 00190660143817 ()
73-562

  • Hand-held surgical retractor, reusable
Volkman retractor, 8 3/4'', USA pattern, 3 sharp prongs, 18.0mm wide, ring handle
AMBLER SURGICAL CORP.
Volkman retractor
In Commercial Distribution

  • 00190660143794 ()
73-571

  • Hand-held surgical retractor, reusable
Volkman retractor, 8 3/4'', USA pattern, 3 blunt prongs, 18.0mm wide, ring handle
AMBLER SURGICAL CORP.
Volkman retractor
In Commercial Distribution

  • 00190660143770 ()
73-561

  • Hand-held surgical retractor, reusable
Volkman retractor, 8 3/4'', USA pattern, 2 sharp prongs, 11.0mm wide, ring handle
AMBLER SURGICAL CORP.
Volkman retractor
In Commercial Distribution

  • 00190660143756 ()
73-570

  • Hand-held surgical retractor, reusable
Volkman retractor, 8 3/4'', USA pattern, 2 blunt prongs, 11.0mm wide, ring handle
AMBLER SURGICAL CORP.
Volkman retractor
In Commercial Distribution

  • 00190660143732 ()
73-560

  • Hand-held surgical retractor, reusable
Volkman retractor, 8 1/2'', 6 sharp prongs, 28.0mm wide, finger ring handle
AMBLER SURGICAL CORP.
Volkman retractor
In Commercial Distribution

  • 00190660143718 ()
73-533

  • Hand-held surgical retractor, reusable
Volkman retractor, 8 1/2'', 6 blunt prongs, 28.0mm wide, finger ring handle
AMBLER SURGICAL CORP.
Volkman retractor
In Commercial Distribution

  • 00190660143695 ()
73-523

  • Hand-held surgical retractor, reusable
Volkman retractor, 8 1/2'', 4 sharp prongs, 18.0mm wide, finger ring handle
AMBLER SURGICAL CORP.
Volkman retractor
In Commercial Distribution

  • 00190660143671 ()
73-532

  • Hand-held surgical retractor, reusable
Volkman retractor, 8 1/2'', 4 blunt prongs, 18.0mm wide, finger ring handle
AMBLER SURGICAL CORP.
Volkman retractor
In Commercial Distribution

  • 00190660143657 ()
73-522

  • Hand-held surgical retractor, reusable
Volkman retractor, 8 1/2'', 3 sharp prongs, 13.0mm wide, finger ring handle
AMBLER SURGICAL CORP.
Volkman retractor
In Commercial Distribution

  • 00190660143633 ()
73-531

  • Hand-held surgical retractor, reusable
Volkman retractor, 8 1/2'', 3 blunt prongs, 13.0mm wide, finger ring handle
AMBLER SURGICAL CORP.
Volkman retractor
In Commercial Distribution

  • 00190660143619 ()
73-521

  • Hand-held surgical retractor, reusable
Volkman retractor, 8 1/2'', 2 sharp prongs, 8.0mm wide, finger ring handle
AMBLER SURGICAL CORP.
Volkman retractor
In Commercial Distribution

  • 00190660143596 ()
73-530

  • Hand-held surgical retractor, reusable
Volkman retractor, 8 1/2'', 2 blunt prongs, 8.0mm wide, finger ring handle
AMBLER SURGICAL CORP.
Volkman retractor
In Commercial Distribution

  • 00190660143572 ()
73-520

  • Hand-held surgical retractor, reusable
Volkman retractor, 4 1/2'', 6 sharp prongs, 19mm wide, ring handle
AMBLER SURGICAL CORP.
Volkman retractor
In Commercial Distribution

  • 00190660143558 ()
73-513

  • Hand-held surgical retractor, reusable
Volkman retractor, 4 1/2'', 6 blunt prongs, 19mm wide, ring handle
AMBLER SURGICAL CORP.
Volkman retractor
In Commercial Distribution

  • 00190660143534 ()
73-503

  • Hand-held surgical retractor, reusable
Volkman retractor, 4 1/2'', 4 sharp prongs, 13.0mm wide, ring handle
AMBLER SURGICAL CORP.
Volkman retractor
In Commercial Distribution

  • 00190660143510 ()
73-512

  • Hand-held surgical retractor, reusable
Volkman retractor, 4 1/2'', 4 blunt prongs, 13.0mm wide, ring handle
AMBLER SURGICAL CORP.
Volkman retractor
In Commercial Distribution

  • 00190660143497 ()
73-502

  • Hand-held surgical retractor, reusable
Volkman retractor, 4 1/2'', 3 sharp prongs, 10.0mm wide, ring handle
AMBLER SURGICAL CORP.
Volkman retractor
In Commercial Distribution

  • 00190660143473 ()
73-511

  • Hand-held surgical retractor, reusable
Volkman retractor, 4 1/2'', 3 blunt prongs, 10.0mm wide, ring handle
AMBLER SURGICAL CORP.
Volkman retractor
In Commercial Distribution

  • 00190660143459 ()
73-501

  • Hand-held surgical retractor, reusable
Volkman retractor, 4 1/2'', 2 sharp prongs, 8.0mm wide, ring handle
AMBLER SURGICAL CORP.
Volkman retractor
In Commercial Distribution

  • 00190660143435 ()
73-510

  • Hand-held surgical retractor, reusable
Volkman retractor, 4 1/2'', 2 blunt prongs, 8.0mm wide, ring handle
AMBLER SURGICAL CORP.
Volkman retractor
In Commercial Distribution

  • 00190660143411 ()
73-500

  • Hand-held surgical retractor, reusable
Senn finger retractor, 6 1/4'', double-ended, 3 sharp prongs, flat handle
AMBLER SURGICAL CORP.
Senn finger retractor
In Commercial Distribution

  • 00190660141837 ()
73-161

  • Hand-held surgical retractor, reusable
Senn finger retractor, 6 1/4'', double-ended, 3 blunt prongs, flat handle
AMBLER SURGICAL CORP.
Senn finger retractor
In Commercial Distribution

  • 00190660141806 ()
73-160

  • Hand-held surgical retractor, reusable
Ragnell retractor, 6 1/4'', double-ended, 2.5mm x 8.0mm and 5.0mm x 15.0mm wide blades, flat handle
AMBLER SURGICAL CORP.
Ragnell retractor
In Commercial Distribution

  • 00190660140823 ()
72-661

  • Nerve/vessel retractor
Hill-Ferguson rectal retractor, 3'' long x 1 3/8'' wide blade, grip handle
AMBLER SURGICAL CORP.
Hill-Ferguson rectal retractor
In Commercial Distribution

  • 00190660136758 ()
72-122

  • Rectal speculum
Hill-Ferguson rectal retractor, 3'' long x 1 1/4'' wide blade, grip handle
AMBLER SURGICAL CORP.
Hill-Ferguson rectal retractor
In Commercial Distribution

  • 00190660136734 ()
72-121

  • Rectal speculum
Hill-Ferguson rectal retractor, 2 1/2'' long x 15/16'' wide blade, grip handle
AMBLER SURGICAL CORP.
Hill-Ferguson rectal retractor
In Commercial Distribution

  • 00190660136710 ()
72-120

  • Rectal speculum
Gelpi self-retaining retractor, 7 1/2'', sharp points, ring handle with ratchet catch
AMBLER SURGICAL CORP.
Gelpi self-retaining retractor
In Commercial Distribution

  • 00190660135904 ()
71-653

  • Self-retaining surgical retractor, reusable
Gelpi self-retaining retractor, 5 1/2'', sharp points, ring handle with ratchet catch
AMBLER SURGICAL CORP.
Gelpi self-retaining retractor
In Commercial Distribution

  • 00190660135874 ()
71-652

  • Self-retaining surgical retractor, reusable
Gelpi self-retaining retractor, 4 1/2'', sharp points, ring handle with ratchet catch
AMBLER SURGICAL CORP.
Gelpi self-retaining retractor
In Commercial Distribution

  • 00190660135850 ()
71-651

  • Self-retaining surgical retractor, reusable
Gelpi self-retaining retractor, 3 1/2'', sharp points, ring handle with ratchet catch
AMBLER SURGICAL CORP.
Gelpi self-retaining retractor
In Commercial Distribution

  • 00190660135836 ()
71-650

  • Self-retaining surgical retractor, reusable
H2H Rinse Line and packaging information
NEPHROS, INC.
70-5827
Not in Commercial Distribution

  • 10896241002364 ()
  • 00896241002367 ()


  • Haemodialysis water purification system washer-disinfector (thermal)
Hose set for Kavo INTRASurg (10/pkg)
OMNIA SRL
32.F0160.00
In Commercial Distribution

  • 08052141311424 ()
  • 08052141311431 ()


  • Disposable surgical irrigation/aspiration system
Sterilizable Hose Set S600
OMNIA SRL
30.F0341.00
In Commercial Distribution

  • 08052141311400 ()
  • 08052141311417 ()


  • Surgical irrigation tubing set, reusable
Hose set for machinery (10/pkg)
OMNIA SRL
32.F0128.00
In Commercial Distribution

  • 08056646504893 ()
  • 08056646504909 ()


  • Disposable surgical irrigation/aspiration system
Mayo-Hegar needle holder, 5'', straight, serrated TC jaws, gold ring handle
AMBLER SURGICAL CORP.
Mayo-Hegar needle holder
In Commercial Distribution

  • 00190660218843 ()
52-199

  • Suturing needle holder, reusable
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