1
00860005178803
A-SP3US-03K
The Spatz3 Adjustable Balloon System is indicated for temporary use for weight l
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The Spatz3 Adjustable Balloon System is indicated for temporary use for weight loss in adults with obesity Body Mass Index (BMI) of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with one or more major obesity-related comorbid conditions who have failed to achieve and maintain weight-loss with a supervised weight control program. The Spatz3 Adjustable Balloon System is to be used in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of long-term weight-loss maintenance. The maximum placement period for Spatz3 Adjustable Balloon System is 8 months.
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Spatz3 Adjustable Balloon System insertion kit
SPATZ FGIA (ISRAEL) LTD
2
00859810006241
7405-0001
OBALON® Recalibration Tool - component for use with the OBALON® Navigation Console
OBALON®
OBALON THERAPEUTICS, INC.
3
00859810006234
7410-0001
OBALON® Navigation Balloon Kit - Intragastric Balloon
OBALON®
OBALON THERAPEUTICS, INC.
4
00859810006227
9410-0001
OBALON® Navigation Balloon System - contains one OBALON® Navigation Balloon Kit
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OBALON® Navigation Balloon System - contains one OBALON® Navigation Balloon Kit and one OBALON® Accessory Kit - Ejectors
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OBALON®
OBALON THERAPEUTICS, INC.
5
00859810006210
8200-0001
OBALON® Inflation Can - component to inflate the OBALON® Balloon System
OBALON® Inflation Can
OBALON THERAPEUTICS, INC.
6
00859810006203
9300-0001
OBALON Touch™ Dispenser Kit - contains one OBALON Touch™ Dispenser, one OBALON®
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OBALON Touch™ Dispenser Kit - contains one OBALON Touch™ Dispenser, one OBALON® Balloon Evacuator, 1 Screwdriver, and Batteries
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OBALON Touch™
OBALON THERAPEUTICS, INC.
7
00859810006197
7404-0001
OBALON® Reference Sensor Cable - component for use with the OBALON® Navigation Console
OBALON®
OBALON THERAPEUTICS, INC.
8
00859810006180
7402-0001
OBALON® Navigation Console - component to visualize the OBALON® Balloon
OBALON®
OBALON THERAPEUTICS, INC.
9
00859810006173
6300-0001
OBALON® Balloon Evacuator - component for use with the OBALON® Balloon
OBALON®
OBALON THERAPEUTICS, INC.
10
00859810006142
6200-0001
OBALON® Accessory Kit - Ejectors - component for use with the OBALON® Balloon
OBALON®
OBALON THERAPEUTICS, INC.
11
00859810006104
4300-0003
OBALON Touch™ Dispenser - component to inflate the OBALON® Balloon
OBALON Touch™
OBALON THERAPEUTICS, INC.
12
00859810006081
7650-0002
OBALON® Placebo Capsule HPMC - component for use with the OBALON® Balloon System
OBALON® Placebo Capsule HPMC
OBALON THERAPEUTICS, INC.
13
00859810006074
9600-0001
OBALON® Balloon System HPMC - contains one Obalon Balloon Kit HPMC and one Obalo
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OBALON® Balloon System HPMC - contains one Obalon Balloon Kit HPMC and one Obalon Accessory Kit
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OBALON® Balloon System HPMC
OBALON THERAPEUTICS, INC.
14
00859810006067
7600-0001
Intragastric Balloon
OBALON® Balloon Kit HPMC
OBALON THERAPEUTICS, INC.
15
00859810006050
9500-0001
OBALON® Balloon System - contains one Obalon Balloon Kit and one Obalon Accessory Kit
OBALON® Balloon System
OBALON THERAPEUTICS, INC.
16
00859810006043
6000-0004
OBALON® Accessory Kit - component for use with the OBALON® Balloon System
OBALON® Accessory Kit
OBALON THERAPEUTICS, INC.
17
00859810006036
7500-0001
Intragastric Balloon
OBALON® Balloon Kit
OBALON THERAPEUTICS, INC.
18
00859810006029
4200-0001
OBALON® EzFill™ Dispenser - component to inflate the OBALON® Balloon System
OBALON® EzFill™ Dispenser
OBALON THERAPEUTICS, INC.
19
00859810006012
8200-0001
OBALON® EzFill™ Can - component to inflate the OBALON® Balloon System
OBALON® EzFill™ Can
OBALON THERAPEUTICS, INC.
20
00859810006005
7150-0003
OBALON® Placebo Capsule - component for use with the OBALON® Balloon System
OBALON® Placebo Capsule
OBALON THERAPEUTICS, INC.
21
00850007764906
C-20390
C-20390
RapidPort EZ Applier Tool
RapidPort® EZ Port Applier
RESHAPE LIFESCIENCES INC.
22
00850007764654
C-2365
C-2365
The LAP-BAND AP Adjustable Gastric Banding System Large with RapidPort EZ
LAP-BAND AP® System Large with RapidPort® EZ
RESHAPE LIFESCIENCES INC.
23
00850007764609
C-2360
C-2360
The LAP-BAND AP Adjustable Gastric Banding System Standard with RapidPort EZ
LAP-BAND AP® System Standard with RapidPort® EZ
RESHAPE LIFESCIENCES INC.
24
00850007764067
C-2306
C-2306
RapidPort EZ Access Port Kit (0-14cc)
RapidPort® EZ Access Port Kit - 14cc
RESHAPE LIFESCIENCES INC.
25
00850007764043
C-2304
C-2304
RapidPort EZ Access Port Kit (0-10cc)
RapidPort® EZ Access Port Kit - 10cc
RESHAPE LIFESCIENCES INC.
26
B001RSM9001
RSM900
RSM900
ReShape™ Valve Sealant - component for use with the ReShape™ Integrated Dual Balloon
ReShape™ Valve Sealant
RESHAPE MEDICAL, INC.
27
B001RSM2101
RSM210
RSM210
ReShape™ Removal Catheter - component to remove the ReShape™ Integrated Dual Balloon
ReShape™ Removal Catheter
RESHAPE MEDICAL, INC.
28
B001RSM1101
RSM110
RSM110
IMPLANT, INTRAGASTRIC BALLOON FOR OBESITY
ReShape® Integrated Dual Balloon System
RESHAPE MEDICAL, INC.
29
B001RSM1011
RSM101
RSM101
IMPLANT, INTRAGASTRIC BALLOON FOR OBESITY
ReShape™ Integrated Dual Balloon System
RESHAPE MEDICAL, INC.
30
20705036004018
RLZPT2
RLZPT2
Gastric Band Sutureless Port and Applier
NA
OBTECH MEDICAL SÀRL
31
20705036004001
RLZB32
RLZB32
Curved Adjustable Gastric Band with Sutureless Port and Applier
NA
OBTECH MEDICAL SÀRL
32
10850007764330
B-20301-10
B-20301-10
LAP-BAND Access Port Needle 3.5 inch Pouch
LAP-BAND® System Access Port Needle, 20G x 89 mm (3.5 in.)
RESHAPE LIFESCIENCES INC.
33
10850007764323
B-20302-10
B-20302-10
LAP-BAND Access Port Needle 2 inch Pouch
LAP-BAND® System Access Port Needle, 20G x 51 mm (2 in.)
RESHAPE LIFESCIENCES INC.
34
10811955020619
B-4800
B-4800
Intragastric Balloon
ORBERA Intragastric Balloon System
APOLLO ENDOSURGERY, INC.
35
10811955020503
B-20401
B-20401
LAP-BAND System Tubing Kit
LAP-BAND
APOLLO ENDOSURGERY, INC.
36
10811955020428
B-20302
B-20302
LAP-BAND Access Port Needle 2 inch Pouch
LAP-BAND
APOLLO ENDOSURGERY, INC.
37
10811955020411
B-20301
B-20301
LAP-BAND Access Port Needle 3.5 inch Pouch
LAP-BAND
APOLLO ENDOSURGERY, INC.
38
10811955020374
B-2017
B-2017
LAP-BAND System Calibration Tube
LAP-BAND
APOLLO ENDOSURGERY, INC.
39
10811955020312
C-2365
C-2365
The LAP-BAND AP Adjustable Gastric Banding System with RapidPort EZ
LAP-BAND
APOLLO ENDOSURGERY, INC.
40
10811955020305
C-2360
C-2360
The LAP-BAND AP Adjustable Gastric Banding System with RapidPort EZ
LAP-BAND
APOLLO ENDOSURGERY, INC.
41
10811955020299
C-2306
C-2306
RapidPort EZ Access Port Kit
RapidPort EZ
APOLLO ENDOSURGERY, INC.
42
10811955020282
C-2304
C-2304
RapidPort EZ Access Port Kit
RapidPort EZ
APOLLO ENDOSURGERY, INC.
43
10811955020275
B-2365
B-2365
LAP-BAND AP Large with RAPIDPORT EZ
LAP-BAND AP Adjustable Gastric Banding System with RapidPort EZ
APOLLO ENDOSURGERY, INC.
44
10811955020268
B-2360
B-2360
LAP-BAND AP Standard with RAPIDPORT EZ
LAP-BAND AP Adjustable Gastric Banding System with RapidPort EZ
APOLLO ENDOSURGERY, INC.
45
10811955020251
B-2306
B-2306
RAPIDPORT EZ Access Port Kit 14CC
Access Port RapidPort EZ Kit
APOLLO ENDOSURGERY, INC.
46
10811955020244
B-2304
B-2304
RAPIDPORT EZ Access Port Kit 10CC
Access Port RapidPort EZ Kit
APOLLO ENDOSURGERY, INC.
47
10811955020237
B-2265
B-2265
LAP-BAND AP Large with Access Port II
LAP-BAND AP Adjustable Gastric Banding System
APOLLO ENDOSURGERY, INC.
48
10811955020220
B-2260
B-2260
LAP-BAND AP Standard with Access Port II
LAP-BAND AP Adjustable Gastric Banding System
APOLLO ENDOSURGERY, INC.
49
10811955020213
B-2255
B-2255
LAP-BAND VG with ACCESS PORT II (US)
The LAP-BAND Adjustable Gastric Banding System with the Access Port II
APOLLO ENDOSURGERY, INC.
50
10811955020206
B-2250
B-2250
LAP-BAND SYSTEM, VG, STERILE, US
The LAP-BAND Adjustable Gastric Banding System
APOLLO ENDOSURGERY, INC.