1
00864661000133
TH-1031
TH-1031
TraceIT® Tissue Marker is a sterile, single use, product consisting of a pre-fil
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TraceIT® Tissue Marker is a sterile, single use, product consisting of a pre-filled glass syringe containing the synthetic, radiopaque cross-linked PEG hydrogel with an endcap.
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TraceIT Tissue Marker 3mL 1-UP
AUGMENIX, INC.
2
00864661000119
TH-1011
TH-1011
TraceIT® Tissue Marker is a sterile, single use, product consisting of a pre-fil
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TraceIT® Tissue Marker is a sterile, single use, product consisting of a pre-filled glass syringe containing the synthetic, radiopaque cross-linked PEG hydrogel with an endcap.
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TraceIT Tissue Marker 1-UP
AUGMENIX, INC.
3
00863593000273
F-01-03-0115
Nova 10 Fiducial Marker
C4 IMAGING, LLC
4
00863593000259
F-01-03-0111
The Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer c
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The Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a solution of up to 1.0% cobalt chloride and up to 2.0% N-Acetyl cysteine, in a ratio of 1:2. Zirconium oxide is sealed within the device. The length of the polymer capsule is between 5.5 mm and 10.0 mm, and the diameter is 1.0 mm. It is loaded in an implant needle and sterilized with Ethylene Oxide.
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Nova 5
C4 IMAGING, LLC
5
00863593000242
F-01-03-0011
The Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer c
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The Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a solution of up to 1.0% cobalt chloride and up to 2.0% N-Acetyl cysteine, in a ratio of 1:2. Zirconium oxide is sealed within the device. The length of the polymer capsule is between 5.5 mm and 10.0 mm, and the diameter is between 0.9 mm and 1.2 mm.
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Nova 5
C4 IMAGING, LLC
6
00858015005660
040316
040316
Preloaded Tribell Carbon Tissue Marker - Distal Needle Tip Delivery
BiomarC®
CARBON MEDICAL TECHNOLOGIES, INC.
7
00858015005653
040321
040321
Preloaded Tribell Carbon Tissue Marker - Distal Needle Tip Delivery
BiomarC®
CARBON MEDICAL TECHNOLOGIES, INC.
8
00858015005646
040143
040143
Coaxial Needle
BiomarC ®
CARBON MEDICAL TECHNOLOGIES, INC.
9
00858015005592
040240
040240
Preloaded Tribell Carbon Tissue Marker - Sideport Delivery
BiomarC®
CARBON MEDICAL TECHNOLOGIES, INC.
10
00858015005585
040403
040403
Preloaded Carbon Tissue Marker, Needle Tip Delivery
BiomarC®
CARBON MEDICAL TECHNOLOGIES, INC.
11
00858015005493
040201
040201
Tissue Marker System - Stereotactic Delivery
ImarC™
CARBON MEDICAL TECHNOLOGIES, INC.
12
00858015005486
040304
040304
Tissue Marker System - Core Delivery
Imarc™
CARBON MEDICAL TECHNOLOGIES, INC.
13
00858015005479
040303
040303
Tissue Marker System - Core Delivery
ImarC™
CARBON MEDICAL TECHNOLOGIES, INC.
14
00858015005462
040301
040301
Tissue Marker System - Core Delivery
ImarC™
CARBON MEDICAL TECHNOLOGIES, INC.
15
00858015005455
040210
040210
Tissue Marker System - Stereotactic Delivery
ImarC™
CARBON MEDICAL TECHNOLOGIES, INC.
16
00858015005448
STAR1403
STAR1403
Biopsy Site Identifier
MammoStar™
CARBON MEDICAL TECHNOLOGIES, INC.
17
00858015005431
STAR1402
STAR1402
Biopsy Site Identifier
MammoStar™
CARBON MEDICAL TECHNOLOGIES, INC.
18
00858015005424
STAR1401
STAR1401
Biopsy Site Identifier
MammoStar™
CARBON MEDICAL TECHNOLOGIES, INC.
19
00858015005417
STAR1121
STAR1121
Biopsy Site Identifier
MammoStar™
CARBON MEDICAL TECHNOLOGIES, INC.
20
00858015005400
STAR1102
STAR1102
Biopsy Site Identifier
MammoStar™
CARBON MEDICAL TECHNOLOGIES, INC.
21
00858015005394
STAR1101
STAR1101
Biopsy Site Identifier
MammoStar™
CARBON MEDICAL TECHNOLOGIES, INC.
22
00858015005387
STAR1033
STAR1033
Biopsy Site Identifier - Revolve
MammoStar™
CARBON MEDICAL TECHNOLOGIES, INC.
23
00858015005370
STAR1032
STAR1032
Biopsy Site Identifier - Revolve
MammoStar™
CARBON MEDICAL TECHNOLOGIES, INC.
24
00858015005363
STAR1031
STAR1031
Biopsy Site Identifier - Revolve
MammoStar™
CARBON MEDICAL TECHNOLOGIES, INC.
25
00858015005356
STAR1001
STAR1001
Biopsy Site Identifier
MammoStar™
CARBON MEDICAL TECHNOLOGIES, INC.
26
00858015005349
STAR0833
STAR0833
Biopsy Site Identifier - Revolve
MammoStar™
CARBON MEDICAL TECHNOLOGIES, INC.
27
00858015005332
STAR0832
STAR0832
Biopsy Site Identifier - Revolve
MammoStar™
CARBON MEDICAL TECHNOLOGIES, INC.
28
00858015005325
STAR0831
STAR0831
Biopsy Site Identifier - Revolve
MammoStar™
CARBON MEDICAL TECHNOLOGIES, INC.
29
00858015005318
STAR0802
STAR0802
Biopsy Site Identifier
MammoStar™
CARBON MEDICAL TECHNOLOGIES, INC.
30
00858015005301
STAR0801
STAR0801
Biopsy Site Identifier
MammoStar™
CARBON MEDICAL TECHNOLOGIES, INC.
31
00858015005295
040315
040315
Preloaded Carbon Tissue Marker with Enhanced MRI Visibility - Distal Needle Tip Delivery
BiomarC®
CARBON MEDICAL TECHNOLOGIES, INC.
32
00858015005288
040314
040314
Preloaded Barbell Carbon Tissue Marker - Distal Needle Tip Delivery
BiomarC®
CARBON MEDICAL TECHNOLOGIES, INC.
33
00858015005271
040313
040313
Preloaded Barbell Carbon Tissue Marker - Distal Needle Tip Delivery
BiomarC®
CARBON MEDICAL TECHNOLOGIES, INC.
34
00858015005264
040311
040311
Preloaded Carbon Tissue Marker - Distal Delivery
BiomarC®
CARBON MEDICAL TECHNOLOGIES, INC.
35
00858015005257
040238
040238
Preloaded Carbon Tissue Marker with Enhanced MRI Visibility - Sideport Delivery
BiomarC®
CARBON MEDICAL TECHNOLOGIES, INC.
36
00858015005240
040236
040236
Preloaded Barbell Carbon Tissue Marker - Sideport Delivery
BiomarC®
CARBON MEDICAL TECHNOLOGIES, INC.
37
00858015005233
040234
040234
Preloaded Barbell Carbon Tissue Marker, Sideport Delivery
BiomarC®
CARBON MEDICAL TECHNOLOGIES, INC.
38
00858015005226
040230
040230
Preloaded Barbell Carbon Tissue Marker - Distal Delivery
BiomarC®
CARBON MEDICAL TECHNOLOGIES, INC.
39
00858015005219
040229
040229
Preloaded Barbell Carbon Tissue Marker - Sideport Delivery
BiomarC®
CARBON MEDICAL TECHNOLOGIES, INC.
40
00858015005202
040132
040132
Carbon Tissue Marker System with Enhanced Visibility, kV
BiomarC®
CARBON MEDICAL TECHNOLOGIES, INC.
41
00858015005189
040123
040123
Carbon Tissue Marker System with Enhanced Visibility, kV
BiomarC®
CARBON MEDICAL TECHNOLOGIES, INC.
42
00858015005172
040122
040122
Carbon Tissue Marker System with Enhanced Visibility, kV
BiomarC®
CARBON MEDICAL TECHNOLOGIES, INC.
43
00858015005165
040121
040121
Carbon Tissue Marker System, kV
BiomarC®
CARBON MEDICAL TECHNOLOGIES, INC.
44
00858015005141
040119
040119
Carbon Tissue Marker System, kV
BiomarC®
CARBON MEDICAL TECHNOLOGIES, INC.
45
00858015005127
040109
040109
Carbon Tissue Marker System, kV
BiomarC®
CARBON MEDICAL TECHNOLOGIES, INC.
46
00858015005110
040402
040402
Preloaded Carbon Tissue Marker, Distal Delivery
BiomarC®
CARBON MEDICAL TECHNOLOGIES, INC.
47
00858015005103
040401
040401
Preloaded Carbon Tissue Marker, Needle Tip Delivery
BiomarC®
CARBON MEDICAL TECHNOLOGIES, INC.
48
00858015005097
040400
040400
Preloaded Carbon Tissue Marker, Needle Tip Delivery
BiomarC®
CARBON MEDICAL TECHNOLOGIES, INC.
49
00858015005066
040101
040101
Tissue Marker, kV
BiomarC ®
CARBON MEDICAL TECHNOLOGIES, INC.
50
00858015005042
040139
040139
Fiducial Marker System, PRO
BiomarC®
CARBON MEDICAL TECHNOLOGIES, INC.