1
00850007764906
C-20390
C-20390
RapidPort EZ Applier Tool
RapidPort® EZ Port Applier
RESHAPE LIFESCIENCES INC.
2
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.
3
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.
4
00850007764067
C-2306
C-2306
RapidPort EZ Access Port Kit (0-14cc)
RapidPort® EZ Access Port Kit - 14cc
RESHAPE LIFESCIENCES INC.
5
00850007764043
C-2304
C-2304
RapidPort EZ Access Port Kit (0-10cc)
RapidPort® EZ Access Port Kit - 10cc
RESHAPE LIFESCIENCES INC.
6
B001RSM9001
RSM900
RSM900
ReShape™ Valve Sealant - component for use with the ReShape™ Integrated Dual Balloon
ReShape™ Valve Sealant
RESHAPE MEDICAL, INC.
7
B001RSM2101
RSM210
RSM210
ReShape™ Removal Catheter - component to remove the ReShape™ Integrated Dual Balloon
ReShape™ Removal Catheter
RESHAPE MEDICAL, INC.
8
B001RSM1101
RSM110
RSM110
IMPLANT, INTRAGASTRIC BALLOON FOR OBESITY
ReShape® Integrated Dual Balloon System
RESHAPE MEDICAL, INC.
9
B001RSM1011
RSM101
RSM101
IMPLANT, INTRAGASTRIC BALLOON FOR OBESITY
ReShape™ Integrated Dual Balloon System
RESHAPE MEDICAL, INC.
10
20705036004018
RLZPT2
RLZPT2
Gastric Band Sutureless Port and Applier
NA
OBTECH MEDICAL SÀRL
11
20705036004001
RLZB32
RLZB32
Curved Adjustable Gastric Band with Sutureless Port and Applier
NA
OBTECH MEDICAL SÀRL
12
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.
13
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.
14
10811955020619
B-4800
B-4800
Intragastric Balloon
ORBERA Intragastric Balloon System
APOLLO ENDOSURGERY, INC.
15
10811955020503
B-20401
B-20401
LAP-BAND System Tubing Kit
LAP-BAND
APOLLO ENDOSURGERY, INC.
16
10811955020428
B-20302
B-20302
LAP-BAND Access Port Needle 2 inch Pouch
LAP-BAND
APOLLO ENDOSURGERY, INC.
17
10811955020411
B-20301
B-20301
LAP-BAND Access Port Needle 3.5 inch Pouch
LAP-BAND
APOLLO ENDOSURGERY, INC.
18
10811955020374
B-2017
B-2017
LAP-BAND System Calibration Tube
LAP-BAND
APOLLO ENDOSURGERY, INC.
19
10811955020312
C-2365
C-2365
The LAP-BAND AP Adjustable Gastric Banding System with RapidPort EZ
LAP-BAND
APOLLO ENDOSURGERY, INC.
20
10811955020305
C-2360
C-2360
The LAP-BAND AP Adjustable Gastric Banding System with RapidPort EZ
LAP-BAND
APOLLO ENDOSURGERY, INC.
21
10811955020299
C-2306
C-2306
RapidPort EZ Access Port Kit
RapidPort EZ
APOLLO ENDOSURGERY, INC.
22
10811955020282
C-2304
C-2304
RapidPort EZ Access Port Kit
RapidPort EZ
APOLLO ENDOSURGERY, INC.
23
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.
24
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.
25
10811955020251
B-2306
B-2306
RAPIDPORT EZ Access Port Kit 14CC
Access Port RapidPort EZ Kit
APOLLO ENDOSURGERY, INC.
26
10811955020244
B-2304
B-2304
RAPIDPORT EZ Access Port Kit 10CC
Access Port RapidPort EZ Kit
APOLLO ENDOSURGERY, INC.
27
10811955020237
B-2265
B-2265
LAP-BAND AP Large with Access Port II
LAP-BAND AP Adjustable Gastric Banding System
APOLLO ENDOSURGERY, INC.
28
10811955020220
B-2260
B-2260
LAP-BAND AP Standard with Access Port II
LAP-BAND AP Adjustable Gastric Banding System
APOLLO ENDOSURGERY, INC.
29
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.
30
10811955020206
B-2250
B-2250
LAP-BAND SYSTEM, VG, STERILE, US
The LAP-BAND Adjustable Gastric Banding System
APOLLO ENDOSURGERY, INC.
31
10811955020190
B-2245
B-2245
LAP-BAND AP Large with Access Port I
LAP-BAND AP Adjustable Gastric Banding System
APOLLO ENDOSURGERY, INC.
32
10811955020183
B-2240
B-2240
LAP-BAND AP Standard with Access Port I
LAP-BAND AP Adjustable Gastric Banding System
APOLLO ENDOSURGERY, INC.
33
10811955020176
B-2225
B-2225
LAP-BAND 10.0, ACCESS PORT II, US
The LAP-BAND Adjustable Gastric Banding System with the Access Port II
APOLLO ENDOSURGERY, INC.
34
10811955020169
B-2220
B-2220
LAP-BAND SYSTEM, 10.0, STERILE, US
The LAP-BAND Adjustable Gastric Banding System
APOLLO ENDOSURGERY, INC.
35
10811955020152
B-2215
B-2215
LAP-BAND 9.75 with ACCESS PORT II, US
The LAP-BAND Adjustable Gastric Banding System with the Access Port II
APOLLO ENDOSURGERY, INC.
36
10811955020145
B-2210
B-2210
LAP-BAND SYSTEM, 9.75, STERILE, US
The LAP-BAND Adjustable Gastric Banding System
APOLLO ENDOSURGERY, INC.
37
10811955020138
B-2107
B-2107
Access Port I Kit 0-14CC
LAP-BAND System Access Port I Kit
APOLLO ENDOSURGERY, INC.
38
10811955020121
B-2106
B-2106
Access Port II Kit 0-14CC
LAP-BAND System Access Port II Kit
APOLLO ENDOSURGERY, INC.
39
10811955020114
B-2105
B-2105
Access Port II Kit 0-10CC
LAP-BAND System Access Port II Kit
APOLLO ENDOSURGERY, INC.
40
10811955020107
B-2104
B-2104
Access Port I Kit 0-10CC
LAP-BAND System Access Port I Kit
APOLLO ENDOSURGERY, INC.
41
10811955020091
B-2103
B-2103
ACCESS PORT II KIT
LAP-BAND System Access Port II Kit
APOLLO ENDOSURGERY, INC.
42
10811955020084
B-2101
B-2101
Access Port Kit
LAP-BAND System Access Port I Kit
APOLLO ENDOSURGERY, INC.
43
10811955020077
A-20331
A-20331
RAPIDPORT EZ Tubing Kit
RapidPort EZ Tubing Kit
APOLLO ENDOSURGERY, INC.
44
10811955020060
A-20401
A-20401
LAP-BAND TUBING KIT (APOLLO)
LAP-BAND Tubing Kit
APOLLO ENDOSURGERY, INC.
45
10811955020053
C-20390
C-20390
RapidPort EZ Applier Tool
RapidPort EZ
APOLLO ENDOSURGERY, INC.
46
10811955020046
B-20390
B-20390
RAPIDPORT EZ Port Applier
RapidPort EZ Port Applier Tool
APOLLO ENDOSURGERY, INC.
47
10811955020022
A-2017
A-2017
PACKAGED LAP-BAND CAL TUBE (US)
LAP-BAND Calibration Tube
APOLLO ENDOSURGERY, INC.
48
10811955020015
B-20310
B-20310
PRI PACK LAP-BAND ADJUSTMENT KIT (APOLLO)
LAP-BAND System Adjustment Kit
APOLLO ENDOSURGERY, INC.
49
07640130455665
4.0/20-180/140
454347
Oscar PTA
BIOTRONIK AG
50
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