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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12 (D) x 14 (W) x 35 (H)
Pioneer Surgical Technology, Inc.
62-1517-58
Not in Commercial Distribution

  • 00846468056322 ()
62-1517-58

  • Vertebral body prosthesis
TruKlear-Brackets Roth .022" 120 Brackets 3-5 w. hook
Forestadent Bernhard Förster GmbH
C706-2035
In Commercial Distribution

  • EFORC70620351 ()


  • Orthodontic bracket, ceramic
TruKlear-Brackets Roth .022" 60 Brackets 3-5 w. hook
Forestadent Bernhard Förster GmbH
C706-2034
In Commercial Distribution

  • EFORC70620341 ()


  • Orthodontic bracket, ceramic
TruKlear-Brackets Roth .022" 20 Brackets 3-5 w. hook
Forestadent Bernhard Förster GmbH
C706-2033
In Commercial Distribution

  • EFORC70620331 ()


  • Orthodontic bracket, ceramic
TruKlear-Brackets Roth .018" 120 Brackets 3-5 w. hook
Forestadent Bernhard Förster GmbH
C706-2029
In Commercial Distribution

  • EFORC70620291 ()


  • Orthodontic bracket, ceramic
TruKlear-Brackets Roth .018" 60 Brackets 3-5 w. hook
Forestadent Bernhard Förster GmbH
C706-2028
In Commercial Distribution

  • EFORC70620281 ()


  • Orthodontic bracket, ceramic
TruKlear-Brackets Roth .018" 20 Brackets 3-5 w. hook
Forestadent Bernhard Förster GmbH
C706-2027
In Commercial Distribution

  • EFORC70620271 ()


  • Orthodontic bracket, ceramic
5.0 NX Extremity Nail 35 mm 1/pkg
FIELD ORTHOPAEDICS PTY LTD
APN000895
In Commercial Distribution

  • 09353903003267 ()
NXNC-5035/1

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
4.0 NX Extremity Nail 35 mm 1/pkg
FIELD ORTHOPAEDICS PTY LTD
APN000894
In Commercial Distribution

  • 09353903003250 ()
NXNC-4035/1

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.5 NX Extremity Nail 35 mm 1/pkg
FIELD ORTHOPAEDICS PTY LTD
APN000893
In Commercial Distribution

  • 09353903003243 ()
NXNC-3535/1

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Profile 0 35 Gap Plate Sterile Qty 2
OSTEOMED LLC
218-0215-SP-02
In Commercial Distribution

  • 00845694065900 ()

  • Length: 39 Millimeter
218-0215-SP-02

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
SENSOR,PULSE OX,ADLT,DISP,FOAM,35" L
MEDLINE INDUSTRIES, INC.
HCSPS20ADF
In Commercial Distribution

  • 20193489027867 ()
  • 10193489027860 ()
HCSPS20ADF

  • Pulse oximeter probe, single-use
10 (D) x 12 (W) x 35 (H)
Pioneer Surgical Technology, Inc.
62-1012-59
Not in Commercial Distribution

  • 00846468055257 ()
62-1012-59

  • Vertebral body prosthesis
10 (D) x 12 (W) x 35 (H)
Pioneer Surgical Technology, Inc.
62-1012-58
Not in Commercial Distribution

  • 00846468055240 ()
62-1012-58

  • Vertebral body prosthesis
Envy NP9 Mattress (Alliance Style) 35" X 88"
SIZEWISE RENTALS, L.L.C.
ENVY NP93588
In Commercial Distribution

  • 00845699002603 ()


  • Flotation therapy bed, adult
SW Envy NPT3 Adapt (Alliance ) 35" x 88"
SIZEWISE RENTALS, L.L.C.
ENVY NPT33588
In Commercial Distribution

  • 00845699002597 ()


  • Flotation therapy bed, adult
220V Sapphire 1100 Blower 35" (Rev 1 & 2)
SIZEWISE RENTALS, L.L.C.
61350006
In Commercial Distribution

  • 00845699001675 ()


  • Alternating-pressure inflator
Patellar, On set, 3 pegs, Larger, 35 mm
UNITED ORTHOPEDIC CORP.
2403-1040
In Commercial Distribution

  • 04712602348911 ()

  • 35mm
2403-1040

  • Cruciate-retaining total knee prosthesis
3700 OEM PNT HTD 22 LG/ 35 SM
HANS RUDOLPH, INC.
3700
Not in Commercial Distribution

  • 00874750007158 ()
113059

  • Pneumotachograph
STERILE DISPOSABLE EQUIPMENT COVER - DOME COVER 35" DEPTH
PREFERRED MEDICAL PRODUCTS, LLC
SC-80
In Commercial Distribution

  • 10680211002566 ()
  • 00680211002569 ()
SC-80

  • Patient surgical drape, single-use
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, 10MM
Exactech, Inc.
02-011-06-0592
In Commercial Distribution

  • 10885862625946 ()
02-011-06-0592

  • 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, 10MM
Exactech, Inc.
02-011-06-0492
In Commercial Distribution

  • 10885862625885 ()
02-011-06-0492

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

  • H93395025 ()
95025

  • Alternating-pressure bed mattress system
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
KOCHER-LANGENBECK RETRACTOR 35 X 11MM LENGTH 215 MM
Gimmi GmbH
AD.1320.03
In Commercial Distribution

  • 04049047015888 ()
AD.1320.03

  • Hand-held surgical retractor, reusable
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
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
Blades (pair) f. MRP-1 60 x 35 mm
Fehling Instruments GmbH & Co. KG
MRP-4
In Commercial Distribution

  • 04058749045291 ()
MRP-4

  • Surgical retractor/retraction system blade, reusable
Blades (pair) f. MRP-1 40 x 35 mm
Fehling Instruments GmbH & Co. KG
MRP-2
In Commercial Distribution

  • 04058749045246 ()
MRP-2

  • Surgical retractor/retraction system blade, reusable
Screw, cannulated, Ø 4.5 mm, length 35 mm
Ulrich GmbH & Co. KG
CS 3907-45-35
In Commercial Distribution

  • 04052536084555 ()
CS 3907-45-35

  • Spinal bone screw, non-bioabsorbable
Screw, pre-fixation, Ø 4.5 mm, length 35 mm
Ulrich GmbH & Co. KG
CS 3804-045-035
In Commercial Distribution

  • 04052536079414 ()
CS 3804-045-035

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Self-tapping), Ø7.5, 35, 127mm
L&K BIOMED CO. ,LTD.
2632-7535S
In Commercial Distribution

  • 08806344394964 ()


  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Self-tapping), Ø6.5, 35, 127mm
L&K BIOMED CO. ,LTD.
2632-6535S
In Commercial Distribution

  • 08806344394896 ()


  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Self-tapping), Ø5.5, 35, 127mm
L&K BIOMED CO. ,LTD.
2632-5535S
In Commercial Distribution

  • 08806344394827 ()


  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Self-tapping), Ø7.5, 35, 117mm
L&K BIOMED CO. ,LTD.
2631-7535S
In Commercial Distribution

  • 08806344394759 ()


  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Self-tapping), Ø6.5, 35, 117mm
L&K BIOMED CO. ,LTD.
2631-6535S
In Commercial Distribution

  • 08806344394681 ()


  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Self-tapping), Ø5.5, 35, 117mm
L&K BIOMED CO. ,LTD.
2631-5535S
In Commercial Distribution

  • 08806344394612 ()


  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Self-tapping), Ø7.5, 35, 107mm
L&K BIOMED CO. ,LTD.
2630-7535S
In Commercial Distribution

  • 08806344394544 ()


  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Self-tapping), Ø6.5, 35, 107mm
L&K BIOMED CO. ,LTD.
2630-6535S
In Commercial Distribution

  • 08806344394476 ()


  • Spinal bone screw, non-bioabsorbable
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