FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NA
DI: 20705036004001
·
Model: RLZB32
·
Obtech Medical Sàrl
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 20705036004001
- Version / Model
- RLZB32
- Catalog Number
- RLZB32
- Company Name
- Obtech Medical Sàrl
- Labeler DUNS
- 486911852
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-17
- Public Version
- 3
- Public Version Date
- 2019-11-07
- Public Version Status
- Update
- Public Device Record Key
- b613f8de-d711-4938-b936-61b3821b8b76
- Distribution End Date
- 2019-11-06
Device Description
Curved Adjustable Gastric Band with Sutureless Port and Applier
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LTI | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17649 | Gastric band | An implantable device in the form of a small belt or strip intended to be surgically (open surgery or laparoscopically) placed around the proximal part of the stomach to create a small pouch with a narrowed outlet (stoma) that divides the stomach into two portions. Commonly known as a lap-band, it is used for weight loss in overweight/obese patients by attempting to restrict the quantity of food consumed by increasing the sense of satiety (fullness). The device typically has an inflatable band used to control the amount of constriction on the stomach; this is adjusted by percutaneous injection of, e.g., saline, into a subcutaneous access port connected by a tube to the device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30705036004008 | GS1 | CASE | 16 | Not in Commercial Distribution | 2019-11-06 |
| Primary | 20705036004001 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature