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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A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
S.D. SIGHT DIAGNOSTICS LTD
TK1
Not in Commercial Distribution

  • B787TK10 ()
  • B787TK11 ()
  • B787TK12 ()


  • Full blood count IVD, kit, cell count
Single-Use Steerable Basket
EndoTheia, Inc.
FSA-120-21
In Commercial Distribution

  • G380FSA120210 ()
  • G380FSA120211 ()
  • G380FSA120212 ()


  • Urinary stone retrieval basket, single-use
Disposable breath alcohol test
Alcopro Inc.
CP08
In Commercial Distribution

  • G354CCP082002 ()
  • G354CCP082001 ()
  • G354CCP082003 ()
  • G354CCP082000 ()
CCP08200

  • Alcohol breath analyser
Disposable breath alcohol test
Alcopro Inc.
CP04
In Commercial Distribution

  • G354CCP042002 ()
  • G354CCP042001 ()
  • G354CCP042003 ()
  • G354CCP042000 ()
CCP04200

  • Alcohol breath analyser
Disposable breath alcohol test
Alcopro Inc.
CP02
In Commercial Distribution

  • G354CCP022001 ()
  • G354CCP022002 ()
  • G354CCP022003 ()
  • G354CCP022000 ()
CCP02200

  • Alcohol breath analyser
NDL, RBN-132, STERILE, F/G
RANFAC CORP.
13 GAUGE x 2"
In Commercial Distribution

  • M9797405005M9 ()
  • M9797405005M1 ()
  • M9797405005M0 ()

  • Needle Gauge: 13 Gauge
  • Length: 2 Inch
RBN-132

  • Bone marrow biopsy needle, single-use
NDL, RBN-114, STERILE, F/G PN 74050-01M
RANFAC CORP.
11 GAUGE x 4"
In Commercial Distribution

  • M9797405001M9 ()
  • M9797405001M1 ()
  • M9797405001M0 ()

  • Length: 4 Inch
  • Needle Gauge: 11 Gauge
RBN-114

  • Bone marrow biopsy needle, single-use
ORC-A, F/G ASSY, RANFAC, 18 GA PN 68084-01M
RANFAC CORP.
18 GAUGE
In Commercial Distribution

  • M9796808401M9 ()
  • M9796808401M1 ()
  • M9796808401M0 ()

  • Needle Gauge: 18 Gauge
ORC-A-18

  • Rigid endoscopic cannula, single-use
GALACTOGRAPHY INFUSION, 31 GA GIU-31 PN 68008-06M
RANFAC CORP.
31 GAUGE
In Commercial Distribution

  • M9796800806M9 ()
  • M9796800806M1 ()
  • M9796800806M0 ()

  • Needle Gauge: 31 Gauge
GIU-31

  • Breast ductography cannula
SIALOGRAPHY UNIT ENDPORT, 30GA 30G-END PN 68008-03M
RANFAC CORP.
30 Gauge
In Commercial Distribution

  • M9796800803M9 ()
  • M9796800803M1 ()
  • M9796800803M0 ()

  • Needle Gauge: 30 Gauge
30G-END

  • Salivary gland catheter
RANFAC BREAST MRK, 7.5CM F/G SBS-7.5 PN 60004-03M
RANFAC CORP.
7.5 CM
In Commercial Distribution

  • M9796000403M9 ()
  • M9796000403M1 ()
  • M9796000403M0 ()

  • Length: 7.5 Centimeter
SBS-7.5

  • Needle guide, single-use
RANFAC BREAST MRK, 10CM F/G SBS-10 PN 60004-02M
RANFAC CORP.
10CM
In Commercial Distribution

  • M9796000402M9 ()
  • M9796000402M1 ()
  • M9796000402M0 ()

  • Length: 10 Centimeter
SBS-10

  • Needle guide, single-use
RANFAC BREAST MRK, 5CM F/G SBS-5 PN 60004-01M
RANFAC CORP.
5CM
In Commercial Distribution

  • M9796000401M9 ()
  • M9796000401M1 ()
  • M9796000401M0 ()

  • Length: 5 Centimeter
SBS-5

  • Needle guide, single-use
Permanent Tissue-Integrating Surgical Matrix
CORNEAT VISION LTD
1007691
In Commercial Distribution

  • G16010362951 ()
  • G16010362950 ()
  • G16010362952 ()

  • 5.0 mm X 6.5 mm X 100 um
1036295

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
MACINTOSH Laryngoscope blade fig 4, conventional with LED and medium plastic handle combination, battery included, single patient use, non-sterile, metal flap, working length (139 mm) (pack of 10)
Carnegie Surgical LLC
404-6648
In Commercial Distribution

  • G14140466481 ()
  • G14140466480 ()
  • G14140466482 ()
404-6648

  • Rigid intubation laryngoscope, single-use
MACINTOSH Laryngoscope blade fig 4, conventional with LED and small plastic handle combination, battery included, single patient use, non-sterile, metal flap, working length (139 mm) (pack of 10)
Carnegie Surgical LLC
404-6647
In Commercial Distribution

  • G14140466471 ()
  • G14140466470 ()
  • G14140466472 ()
404-6647

  • Rigid intubation laryngoscope, single-use
MACINTOSH Laryngoscope blade fig 3.5, conventional with LED and medium plastic handle combination, battery included, single patient use, non-sterile, metal flap, working length (131 mm) (pack of 10)
Carnegie Surgical LLC
404-66385
In Commercial Distribution

  • G141404663851 ()
  • G141404663850 ()
  • G141404663852 ()
404-66385

  • Rigid intubation laryngoscope, single-use
MACINTOSH Laryngoscope blade fig 3, conventional with LED and medium plastic handle combination, battery included, single patient use, non-sterile, metal flap, working length (111 mm) (pack of 10)
Carnegie Surgical LLC
404-6638
In Commercial Distribution

  • G14140466381 ()
  • G14140466380 ()
  • G14140466382 ()
404-6638

  • Rigid intubation laryngoscope, single-use
MACINTOSH Laryngoscope blade fig 3, conventional with LED and small plastic handle combination, battery included, single patient use, non-sterile, metal flap, working length (111 mm) (pack of 10)
Carnegie Surgical LLC
404-6637
In Commercial Distribution

  • G14140466371 ()
  • G14140466370 ()
  • G14140466372 ()
404-6637

  • Rigid intubation laryngoscope, single-use
MACINTOSH Laryngoscope blade fig 2, conventional with LED and medium plastic handle combination, battery included, single patient use, non-sterile, metal flap, working length (93 mm) (pack of 10)
Carnegie Surgical LLC
404-6628
In Commercial Distribution

  • G14140466281 ()
  • G14140466280 ()
  • G14140466282 ()
404-6628

  • Rigid intubation laryngoscope, single-use
MACINTOSH Laryngoscope blade fig 2, conventional with LED and small plastic handle combination, battery included, single patient use, non-sterile, metal flap, working length (93 mm) (pack of 10)
Carnegie Surgical LLC
404-6627
In Commercial Distribution

  • G14140466271 ()
  • G14140466270 ()
  • G14140466272 ()
404-6627

  • Rigid intubation laryngoscope, single-use
MACINTOSH laryngoscope blade fig 4, conventional with LED and Stubby Handle Combination, Battery included, single patient use, non-sterile, metal flap, working length 5 1/2” (139 mm) (Pack of 10)
Carnegie Surgical LLC
404-6449
In Commercial Distribution

  • G14140464491 ()
  • G14140464490 ()
  • G14140464492 ()
404-6449

  • Rigid intubation laryngoscope, single-use
MACINTOSH laryngoscope blade fig 4, conventional with LED and Small Handle Combination, Battery included, single patient use, non-sterile, metal flap, working length (139 mm) (Pack of 10)
Carnegie Surgical LLC
404-6447
In Commercial Distribution

  • G14140464471 ()
  • G14140464470 ()
  • G14140464472 ()
404-6447

  • Rigid intubation laryngoscope, single-use
MACINTOSH laryngoscope blade fig 4, conventional, with LED, single patient use, non-sterile, metal flap, working length 5 1/4” (134 mm) (Pack of 20)
Carnegie Surgical LLC
404-644
In Commercial Distribution

  • G1414046441 ()
  • G1414046440 ()
  • G1414046442 ()
404-644

  • Laryngoscope blade, single-use
MACINTOSH laryngoscope blade fig 3.5, conventional with LED and Medium Handle Combination, Battery included, single patient use, non-sterile, metal flap, working length 5 1/4” (131 mm) (Pack of 10)
Carnegie Surgical LLC
404-64385
In Commercial Distribution

  • G141404643851 ()
  • G141404643850 ()
  • G141404643852 ()
404-64385

  • Rigid intubation laryngoscope, single-use
MACINTOSH laryngoscope blade fig 3, conventional with LED and Small Handle Combination, Battery included, single patient use, non-sterile, metal flap, working length (111 mm) (Pack of 10)
Carnegie Surgical LLC
404-6437
In Commercial Distribution

  • G14140464371 ()
  • G14140464370 ()
  • G14140464372 ()
404-6437

  • Laryngoscope blade, single-use
MACINTOSH laryngoscope blade fig 3, green system, single patient use, non-sterile, metal flap, working length 4 1/2” (112 mm) (Pack of 20)
Carnegie Surgical LLC
404-633
In Commercial Distribution

  • G1414046331 ()
  • G1414046330 ()
  • G1414046332 ()
404-633

  • Laryngoscope blade, single-use
MACINTOSH laryngoscope blade fig 2, green system, single patient use, non-sterile, metal flap, working length 3 5/8” (91 mm) (Pack of 20)
Carnegie Surgical LLC
404-632
In Commercial Distribution

  • G1414046321 ()
  • G1414046320 ()
  • G1414046322 ()
404-632

  • Laryngoscope blade, single-use
MACINTOSH laryngoscope blade fig 1, green system, single patient use, non-sterile, metal flap, working length 2 3/4” (72 mm) (Pack of 20)
Carnegie Surgical LLC
404-631
In Commercial Distribution

  • G1414046311 ()
  • G1414046310 ()
  • G1414046312 ()
404-631

  • Laryngoscope blade, single-use
MACINTOSH Laryngoscope blade fig 00, green system, disposable, non-sterile, metal flap, working length (40 mm) (pack of 20)
Carnegie Surgical LLC
404-629
In Commercial Distribution

  • G1414046291 ()
  • G1414046290 ()
  • G1414046292 ()
404-629

  • Laryngoscope blade, single-use
MACINTOSH laryngoscope blade fig 3, green system, all plastic, single patient use, non-sterile, working length 4 3/8” (110 mm) (Pack of 20)
Carnegie Surgical LLC
404-6283
In Commercial Distribution

  • G14140462831 ()
  • G14140462830 ()
  • G14140462832 ()
404-6283

  • Laryngoscope blade, single-use
MACINTOSH laryngoscope blade fig 2, green system, all plastic, single patient use, non-sterile, working length 3 3/8” (91 mm) (Pack of 20)
Carnegie Surgical LLC
404-6282
In Commercial Distribution

  • G14140462821 ()
  • G14140462820 ()
  • G14140462822 ()
404-6282

  • Laryngoscope blade, single-use
Laryngoscope green system single patient use plastic handle, size small, with LED lamps & batteries, non-sterile, pack in 10 pcs
Carnegie Surgical LLC
404-5621
In Commercial Distribution

  • G14140456211 ()
  • G14140456210 ()
  • G14140456212 ()
404-5621

  • Laryngoscope handle, single-use
Laryngoscope green system handle, single use, medium (requires 2C batteries, not included), aluminium, with LED lamp (Pack of 10)
Carnegie Surgical LLC
404-5110
In Commercial Distribution

  • G14140451101 ()
  • G14140451100 ()
  • G14140451102 ()
404-5110

  • Laryngoscope handle, single-use
MAGILL Intubation forceps, Intubation aid, made of stainless steel, single use, size adult, box of 10 pcs, length 9.5” (24 cm)
Carnegie Surgical LLC
304-080
In Commercial Distribution

  • G1413040801 ()
  • G1413040800 ()
  • G1413040802 ()
304-080

  • Airway tube forceps, single-use
MACINTOSH Laryngoscope blade fig 1, conventional with LED and small plastic handle combination, battery included, single patient use, non-sterile, metal flap, working length (74 mm) (pack of 10)
Carnegie Surgical LLC
404-6617
In Commercial Distribution

  • G14140466171 ()
  • G14140466170 ()
  • G14140466172 ()
404-6617

  • Rigid intubation laryngoscope, single-use
MACINTOSH laryngoscope blade fig 4, conventional with LED and Medium Handle Combination, Battery included, single patient use, non-sterile, metal flap, working length 5 1/2” (139 mm) (Pack of 10)
Carnegie Surgical LLC
404-6448
In Commercial Distribution

  • G14140464481 ()
  • G14140464480 ()
  • G14140464482 ()
404-6448

  • Rigid intubation laryngoscope, single-use
MACINTOSH laryngoscope blade fig 3, conventional with LED and Stubby Handle Combination, Battery included, single patient use, non-sterile, metal flap, working length 4 1/2” (111 mm) (Pack of 10)
Carnegie Surgical LLC
404-6439
In Commercial Distribution

  • G14140464391 ()
  • G14140464390 ()
  • G14140464392 ()
404-6439

  • Rigid intubation laryngoscope, single-use
MACINTOSH laryngoscope blade fig 3, conventional with LED and Medium Handle Combination, Battery included, single patient use, non-sterile, metal flap, working length 4 1/2” (111 mm) (Pack of 10)
Carnegie Surgical LLC
404-6438
In Commercial Distribution

  • G14140464381 ()
  • G14140464380 ()
  • G14140464382 ()
404-6438

  • Rigid intubation laryngoscope, single-use
MACINTOSH laryngoscope blade fig 3, conventional, with LED, single patient use, non-sterile, metal flap, working length 3 5/8” (111 mm) (Pack of 20)
Carnegie Surgical LLC
404-643
In Commercial Distribution

  • G1414046431 ()
  • G1414046430 ()
  • G1414046432 ()
404-643

  • Laryngoscope blade, single-use
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