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The CrossGlide Endometrial Tissue Sampler (ETS Plus) is comprised of a Delivery Catheter with a 6 Fr Biopsy Device and everting
membrane that accesses the cervix and uterine cavity and a 3cc syringe with an attachable compliant tube assembly for supplying
saline to the Delivery Catheter. The 3cc syringe is also used for supplying negative pressure in the ETS. The Delivery Catheter
contains an acorn tip as an aid in seating its distal end at the exocervix.
CROSS BAY MEDICAL, INC.
ETS Plus
In Commercial Distribution
- 00850012760061 ()
CBPN3003
- Endometrial biopsy curette
The CrossGlide Endometrial Tissue Sampler (ETS) is comprised of a Delivery Catheter with a 6 Fr Biopsy Device and everting
membrane that accesses the cervix and uterine cavity and a 3cc syringe with an attachable compliant tube assembly for supplying
saline to the Delivery Catheter. The 3cc syringe is also used for supplying negative pressure in the ETS. The Delivery Catheter
contains an acorn tip as an aid in seating its distal end at the exocervix.
CROSS BAY MEDICAL, INC.
CBPN3001
In Commercial Distribution
- 00850012760054 ()
- 10850012760051 ()
- Endometrial biopsy kit
dental air Driven handpiece
Osseo Scientific LLC
NT-PG-U
In Commercial Distribution
- 00850012724292 ()
- Dental precision attachment fitting/adjustment tool
dental air Driven handpiece
Osseo Scientific LLC
NT-PG-III
In Commercial Distribution
- 00850012724285 ()
- Dental precision attachment fitting/adjustment tool
dental air Driven handpiece
Osseo Scientific LLC
NT-PG-II
In Commercial Distribution
- 00850012724278 ()
- Dental precision attachment fitting/adjustment tool
dental Attachement
Osseo Scientific LLC
NTS-14-FG
In Commercial Distribution
- 00850012724261 ()
- Dental precision attachment fitting/adjustment tool
dental Attachement
Osseo Scientific LLC
NTS-14
In Commercial Distribution
- 00850012724254 ()
- Dental precision attachment fitting/adjustment tool
dental Attachement
Osseo Scientific LLC
NT-PG-SNC-H
In Commercial Distribution
- 00850012724247 ()
- Dental precision attachment fitting/adjustment tool
dental Attachement
Osseo Scientific LLC
NT-PG-SNC-C
In Commercial Distribution
- 00850012724230 ()
- Dental precision attachment fitting/adjustment tool
dental Attachement
Osseo Scientific LLC
INT-SNC
In Commercial Distribution
- 00850012724223 ()
- Dental precision attachment fitting/adjustment tool
dental air driven handpiece
Osseo Scientific LLC
INT-D
In Commercial Distribution
- 00850012724216 ()
- Dental precision attachment fitting/adjustment tool
dental air Driven handpiece
Osseo Scientific LLC
INT-E
In Commercial Distribution
- 00850012724209 ()
- Dental precision attachment fitting/adjustment tool
dental Attachement
Osseo Scientific LLC
NTE-14
In Commercial Distribution
- 00850012724179 ()
- Dental precision attachment fitting/adjustment tool
dental Attachement
Osseo Scientific LLC
NTE-11
In Commercial Distribution
- 00850012724162 ()
- Dental precision attachment fitting/adjustment tool
dental air Driven handpiece
Osseo Scientific LLC
NTE-M5
In Commercial Distribution
- 00850012724155 ()
- Dental precision attachment fitting/adjustment tool
dental air Driven handpiece
Osseo Scientific LLC
NTE-M20
In Commercial Distribution
- 00850012724148 ()
- Dental precision attachment fitting/adjustment tool
dental Attachement
Osseo Scientific LLC
NT-PG-SNC-M
In Commercial Distribution
- 00850012724131 ()
- Dental precision attachment fitting/adjustment tool
Disposable Conductive Plastic Electrode Set, MR/CT Compatible, 27 leads, soft cup, with disposable 27 lead harness
IVES EEG SOLUTIONS, LLC
DCPEX-27/S
In Commercial Distribution
- 00850012681250 ()
DCPEX-27/S
- Analytical scalp electrode, single-use
Disposable Conductive Plastic Electrode Set, MR/CT Compatible, 25 leads, soft cup, with disposable 25 lead harness
IVES EEG SOLUTIONS, LLC
DCPEX-25/S
In Commercial Distribution
- 00850012681243 ()
DCPEX-25/S
- Analytical scalp electrode, single-use
Disposable Conductive Plastic Electrode Set, MR/CT Compatible, 23 leads, soft cup, with disposable 23 lead harness
IVES EEG SOLUTIONS, LLC
DCPEX-23/S
In Commercial Distribution
- 00850012681236 ()
DCPEX-23/S
- Analytical scalp electrode, single-use
Disposable Conductive Plastic Electrode Set, MR/CT Compatible, 21 leads, soft cup, with disposable 21 lead harness
IVES EEG SOLUTIONS, LLC
DCPEX-21/S
In Commercial Distribution
- 00850012681229 ()
DCPEX-21/S
- Analytical scalp electrode, single-use
Disposable Conductive Plastic Electrode Set, MR/CT Compatible, 27 leads, black cup, with disposable 27 lead harness
IVES EEG SOLUTIONS, LLC
DCPEX-27/B
In Commercial Distribution
- 00850012681212 ()
DCPEX-27/B
- Analytical scalp electrode, single-use
Disposable Conductive Electrode Set, MR/CT Compatible, 25 leads, black cup, with disposable 25 lead harness
IVES EEG SOLUTIONS, LLC
DCPEX-25/B
In Commercial Distribution
- 00850012681205 ()
DCPEX-25/B
- Analytical scalp electrode, single-use
Disposable Conductive Plastic Electrodes, MR/CT Compatible, 23 leads, black cup, with disposable 23 lead harness
IVES EEG SOLUTIONS, LLC
DCPEX-23/B
In Commercial Distribution
- 00850012681199 ()
DCPEX-23/B
- Analytical scalp electrode, single-use
Disposable Conductive Plastic Electrode Set, MR/CT Compatible, 21 leads, black cup, with disposable 21 lead harness
IVES EEG SOLUTIONS, LLC
DCPEX-21/B
In Commercial Distribution
- 00850012681182 ()
DCPEX-21/B
- Analytical scalp electrode, single-use
Ives MR Conditional Electrode System Harness, 27 lead wire harness, MR Unsafe (disconnect from electrode set before CT or MR imaging)
IVES EEG SOLUTIONS, LLC
HAR-27
In Commercial Distribution
- 00850012681113 ()
- Analytical scalp lead
Ives MR Conditional Electrode System Harness, 25 lead wire harness, MR Unsafe (disconnect from electrode set before CT or MR imaging)
IVES EEG SOLUTIONS, LLC
HAR-25
In Commercial Distribution
- 00850012681106 ()
- Analytical scalp lead
Ives MR Conditional Electrode System Harness, 23 lead wire harness, MR Unsafe (disconnect from electrode set before CT or MR imaging)
IVES EEG SOLUTIONS, LLC
HAR-23
In Commercial Distribution
- 00850012681090 ()
- Analytical scalp lead
Ives MR Conditional Electrode System Harness, 21 lead wire harness, MR Unsafe (disconnect from electrode set before CT or MR imaging)
IVES EEG SOLUTIONS, LLC
HAR-21
In Commercial Distribution
- 00850012681083 ()
- Analytical scalp lead
MR Conditional Disposable EEG Soft Cup Electrode System, 27 lead, soft cup, CT compatible
IVES EEG SOLUTIONS, LLC
DCPE-27/S
In Commercial Distribution
- 00850012681076 ()
- 10850012681073 ()
DCPE-27/S
- Analytical scalp electrode, single-use
MR Conditional Disposable EEG Soft Cup Electrode System, 25 lead, soft cups, CT compatible
IVES EEG SOLUTIONS, LLC
DCPE-25/S
In Commercial Distribution
- 00850012681069 ()
- 00850012681168 ()
- Analytical scalp electrode, single-use
MR Conditional Disposable EEG Soft Cup electrode system, 23 lead, soft cups, CT compatible
IVES EEG SOLUTIONS, LLC
DCPE-23/S
In Commercial Distribution
- 00850012681052 ()
- 10850012681059 ()
- Analytical scalp electrode, single-use
MR Conditional Disposable EEG Soft Cup electrode system, 21 lead, soft cups, CT compatible
IVES EEG SOLUTIONS, LLC
DCPE-21/S
In Commercial Distribution
- 00850012681045 ()
- 00850012681137 ()
- 10850012681042 ()
- 20850012681049 ()
- Analytical scalp electrode, single-use
MR Conditional Disposable EEG Cup Electrode System, 27 lead, black cup, CT compatible
IVES EEG SOLUTIONS, LLC
DCPE-27/B
In Commercial Distribution
- 00850012681038 ()
- 10850012681035 ()
DCPE-27/B
- Analytical scalp electrode, single-use
MR Conditional Disposable EEG Cup Electrode System, 25 lead, black cup, CT compatible
IVES EEG SOLUTIONS, LLC
DCPE-25/B
In Commercial Distribution
- 00850012681021 ()
- 10850012681028 ()
- Analytical scalp electrode, single-use
MR Conditional Disposable EEG Cup electrode system, 23 lead, black cup, CT compatible
IVES EEG SOLUTIONS, LLC
DCPE-23/B
In Commercial Distribution
- 00850012681014 ()
- 00850012681144 ()
- 00850012681175 ()
DCPE-23/B
- Analytical scalp electrode, single-use
MR Conditional Disposable EEG Cup Electrode System, 21 lead, black cup, CT compatible
IVES EEG SOLUTIONS, LLC
DCPE-21/B
In Commercial Distribution
- 00850012681007 ()
- 00850012681120 ()
- 10850012681004 ()
- Analytical scalp electrode, single-use
The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow. The Avenda Health Unfold AI Software is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. The device is intended to be used by physicians trained in the oncological workflow in a clinical setting for planning and guidance for clinical, interventional, diagnostic, and/or treatment procedures of the prostate.
Avenda Health, Inc.
v0.9.0
In Commercial Distribution
- 00850012642084 ()
- MRI image interpretive software
The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow. The Avenda Health Unfold AI Software is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. The device is intended to be used by physicians trained in the oncological workflow in a clinical setting for planning and guidance for clinical, interventional, diagnostic, and/or treatment procedures of the prostate.
Avenda Health, Inc.
v0.8.0
In Commercial Distribution
- 00850012642077 ()
- MRI image interpretive software
The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow. The Avenda Health Unfold AI Software is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. The device is intended to be used by physicians trained in the oncological workflow in a clinical setting for planning and guidance for clinical, interventional, diagnostic, and/or treatment procedures of the prostate.
Avenda Health, Inc.
v0.7.0
In Commercial Distribution
- 00850012642060 ()
- MRI image interpretive software