FDA UDI
In Commercial Distribution
🇺🇸 United States
ReShape Lap-Band® 2.0, FLEX Tubing Kit
DI: 00850007764586
·
Model: D-3500
·
Reshape Lifesciences Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ReShape Lap-Band® 2.0, FLEX Tubing Kit
- Primary DI
- 00850007764586
- Version / Model
- D-3500
- Catalog Number
- D-3500
- Company Name
- Reshape Lifesciences Inc.
- Labeler DUNS
- 022894714
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-22
- Public Version
- 1
- Public Version Date
- 2024-01-30
- Public Version Status
- New
- Public Device Record Key
- 307dd0d2-40a0-49e8-bfdd-609b5e324e50
Device Description
ReShape Lap-Band® 2.0, FLEX Tubing Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 47066 | Gastric band repair kit | A collection of sterile devices designed to repair an inflatable gastric band that deflates due to a leakage around the original connector or in the original tubing. It typically includes replacement silicone tubing, stainless steel connectors, a priming needle and an end plug. It may be used during the repositioning or relocating of the access port. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850007764586 | GS1 |
Customer Contacts
- Phone
- 844-937-7374
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P000008 | 048 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use if package is damaged and consult instructions for use