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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MALIBU DLTA SCREW 7.0 DIA X 35 mm
Seaspine Orthopedics Corporation
15-7035
Not in Commercial Distribution

  • 10889981003395 ()

  • 7.0 DIA X 35 mm
15-7035

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 6.5 DIA X 35 mm
Seaspine Orthopedics Corporation
15-6535
In Commercial Distribution

  • 10889981003302 ()

  • 6.5 DIA X 35 mm
15-6535

  • Spinal bone screw, non-bioabsorbable
MALIBU DLTA SCREW 6.0 DIA X 35 mm
Seaspine Orthopedics Corporation
15-6035
Not in Commercial Distribution

  • 10889981003241 ()

  • 6.0 DIA X 35 mm
15-6035

  • Spinal bone screw, non-bioabsorbable
MALIBU DLTA SCREW 5.5 DIA X 35 mm
Seaspine Orthopedics Corporation
15-5535
In Commercial Distribution

  • 10889981003173 ()

  • 5.5 DIA X 35 mm
15-5535

  • Spinal bone screw, non-bioabsorbable
MALIBU DLTA SCREW 5.0 DIA X 35 mm
Seaspine Orthopedics Corporation
15-5035
In Commercial Distribution

  • 10889981003111 ()

  • 5.0 DIA X 35 mm
15-5035

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 4.5 DIA X 35 mm
Seaspine Orthopedics Corporation
15-4535
In Commercial Distribution

  • 10889981003067 ()

  • 4.5 DIA X 35 mm
15-4535

  • Spinal bone screw, non-bioabsorbable
PUMP FSP S0FT 8FR 10FR 35/14 ST
REPRO MED SYSTEMS, INC.
P1F1S181S
In Commercial Distribution

  • 00659443001817 ()
P1F1S181S

  • Emergency airway clearance suction system, manual
PUMP FSP S0FT 14FR 35/14 ST LED
REPRO MED SYSTEMS, INC.
P1F1S114SLED
In Commercial Distribution

  • 00659443001800 ()
P1F1S114SLED

  • Emergency airway clearance suction system, manual
PUMP FSP S0FT 10FR 35/14 NS LED
REPRO MED SYSTEMS, INC.
P1F1S110NLED
In Commercial Distribution

  • 00659443001787 ()
P1F1S110NLED

  • Emergency airway clearance suction system, manual
PUMP FSP SOFT 10FR 35/14 NS ECO
REPRO MED SYSTEMS, INC.
P1F1S110NE
In Commercial Distribution

  • 00659443001770 ()
P1F1S110NE

  • Emergency airway clearance suction system, manual
PUMP FSP RGD 8/10FR 35/14 ST
REPRO MED SYSTEMS, INC.
P1F1R181S
In Commercial Distribution

  • 00659443001657 ()
P1F1R181S

  • Emergency airway clearance suction system, manual
PUMP FSP RIGID ET 10FR 35/14 NS
REPRO MED SYSTEMS, INC.
P1F1E110N
In Commercial Distribution

  • 00659443001589 ()
P1F1E110N

  • Emergency airway clearance suction system, manual
PUMP FSP R/S 10FR 35/14 NS
REPRO MED SYSTEMS, INC.
P1F1B110N
In Commercial Distribution

  • 00659443001497 ()
P1F1B110N

  • Emergency airway clearance suction system, manual
STERNUM SAW BL.RAPID ACT.35/75/0.7/0.9MM
Aesculap AG
GC681R
In Commercial Distribution

  • 04046963839345 ()
GC681R

  • Surgical saw blade, oscillating, reusable
G6 FOAM MATTRESS 35 X 80 X 6
SPAN-AMERICA MEDICAL SYSTEMS, INC.
GEOMATTRESS
In Commercial Distribution

  • H93366580 ()
66580

  • Foam bed mattress
84 X 35 Easy Air LR Hercules Coverlet
SPAN-AMERICA MEDICAL SYSTEMS, INC.
HERCULES
In Commercial Distribution

  • H93353292 ()
53292

  • Alternating-pressure bed mattress system
80 X 35 Easy Air LR Hercules Coverlet
SPAN-AMERICA MEDICAL SYSTEMS, INC.
HERCULES
In Commercial Distribution

  • H93346015 ()
46015

  • Alternating-pressure bed mattress system
CUSTOM CARE NP 78 X 35 WELDED COVER
SPAN-AMERICA MEDICAL SYSTEMS, INC.
CUSTOM CARE
In Commercial Distribution

  • H93337711 ()
37711

  • Foam bed mattress
G6 FOAM MATTRESS 35 X 84 X 6
SPAN-AMERICA MEDICAL SYSTEMS, INC.
GEOMATTRESS
In Commercial Distribution

  • H93330169 ()
30169

  • Foam bed mattress
GM HC 5.5 X 80 X 35 BAGGED
SPAN-AMERICA MEDICAL SYSTEMS, INC.
GEOMATTRESS
In Commercial Distribution

  • H93327652 ()
27652

  • Foam bed mattress
Nephrostomy "HB" Catheter + Fixation Kit - Locking - 10F 35
URESIL, LLC
NCL2-1035HB-KSA
Not in Commercial Distribution

  • H862NCL21035HBKSA2 ()
  • H862NCL21035HBKSA0 ()

  • Catheter Gauge: 10 French
  • Length: 28 Centimeter
NCL2-1035HB-KSA

  • Nephrostomy catheter
Nephrostomy "HB" Catheter + Fixation Kit - Locking - 8F 35
URESIL, LLC
NCL2-0835HB-KSA
Not in Commercial Distribution

  • H862NCL20835HBKSA2 ()
  • H862NCL20835HBKSA0 ()

  • Catheter Gauge: 8 French
  • Length: 28 Centimeter
NCL2-0835HB-KSA

  • Nephrostomy catheter
MATTRESS ONLY MEDILOGIX PG PROTOCOL 80 X 35
SPAN-AMERICA MEDICAL SYSTEMS, INC.
PROTOCOL
In Commercial Distribution

  • H933M82077 ()
M82077

  • Alternating-pressure bed mattress system
MATTRESS ONLY MEDILOGIX PG APM2 80 X 35
SPAN-AMERICA MEDICAL SYSTEMS, INC.
APM/ APM II
In Commercial Distribution

  • H933M58774 ()
M58774

  • Alternating-pressure bed mattress system
TRULIANT POST. AUG. BLOCK TRIAL SZ 3-5, 15MM
Exactech, Inc.
02-011-06-0593
In Commercial Distribution

  • 10885862625953 ()
02-011-06-0593

  • Knee femur prosthesis trial, reusable
TRULIANT POST. AUG. BLOCK TRIAL SZ 3-5, 5MM
Exactech, Inc.
02-011-06-0591
In Commercial Distribution

  • 10885862625939 ()
02-011-06-0591

  • Knee femur prosthesis trial, reusable
TRULIANT DIST. AUG. BLOCK TRIAL SZ 3-5, 15MM
Exactech, Inc.
02-011-06-0493
In Commercial Distribution

  • 10885862625892 ()
02-011-06-0493

  • Knee femur prosthesis trial, reusable
TRULIANT DIST. AUG. BLOCK TRIAL SZ 3-5, 5MM
Exactech, Inc.
02-011-06-0491
In Commercial Distribution

  • 10885862625878 ()
02-011-06-0491

  • Knee femur prosthesis trial, reusable
TRULIANT POST. AUG. BLOCK TRIAL SZ 3-5, 10MM
Exactech, Inc.
02-011-06-0592
In Commercial Distribution

  • 10885862625946 ()
02-011-06-0592

  • Knee femur prosthesis trial, reusable
TRULIANT DIST. AUG. BLOCK TRIAL SZ 3-5, 10MM
Exactech, Inc.
02-011-06-0492
In Commercial Distribution

  • 10885862625885 ()
02-011-06-0492

  • Knee femur prosthesis trial, reusable
ZA COVER, T IN FT, URETHANE, 35"X84"
CURBELL MEDICAL PRODUCTS, INC.
MCZ-3584F
Not in Commercial Distribution

  • 00840828162531 ()
9267

  • Stretcher mattress
VERSA CARE REPLACEMENT FOAM MATTRESS COVER 35"X84"
CURBELL MEDICAL PRODUCTS, INC.
MCV-3584FM
Not in Commercial Distribution

  • 00840828162517 ()
9265

  • Probiotic bed mattress cover
***DISC*IGLI ALLROUND C+ - E 35/36, M -,
MEDI MANUFACTURING, INC.
PJ07135
Not in Commercial Distribution

  • 04046114603696 ()


  • Orthotic insole, prefabricated, non-antimicrobial
Max. 1. Molar band Dura-Fit left 35 welded
Forestadent Bernhard Förster GmbH
2882N9935
In Commercial Distribution

  • EFOR2882N99351 ()


  • Orthodontic metal band
Max. 1. Molar band Dura-Fit left 35 welded
Forestadent Bernhard Förster GmbH
2882N9935-050
In Commercial Distribution

  • EFOR2882N99350501 ()
  • EFOR2882N993505000 ()


  • Orthodontic metal band
Max. 1. Molar band Dura-Fit left 35 welded
Forestadent Bernhard Förster GmbH
2882N9935-010
In Commercial Distribution

  • EFOR2882N99350101 ()
  • EFOR2882N993501000 ()


  • Orthodontic metal band
Max. 1. Molar band Dura-Fit left 35 welded
Forestadent Bernhard Förster GmbH
2882N9935-005
In Commercial Distribution

  • EFOR2882N99350051 ()
  • EFOR2882N993500500 ()


  • Orthodontic metal band
Hand Dressing - 18"x 18" Kerlix 35 ply
Dermapac Inc.
2087
In Commercial Distribution

  • 00810102270153 ()
  • 10810102270150 ()


  • Woven gauze roll/sheet
TLIF TRIAL B TYPE 7˚ 35 X 16
Corentec Co., Ltd
SI.C30.7916
In Commercial Distribution

  • 08800017275376 ()


  • Spinal implant trial
TLIF TRIAL B TYPE 7˚ 35 X 15
Corentec Co., Ltd
SI.C30.7915
In Commercial Distribution

  • 08800017275369 ()


  • Spinal implant trial
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