FDA UDI
In Commercial Distribution
🇺🇸 United States
ReShape Lap-Band® 2.0, FLEX & Access Port, Large
DI: 00850007764555
·
Model: D-3306
·
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 & Access Port, Large
- Primary DI
- 00850007764555
- Version / Model
- D-3306
- Catalog Number
- D-3306
- 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
- 2bd942ab-4be0-4dfe-a28e-3b7567d94750
Device Description
ReShape Lap-Band® 2.0, FLEX & Access Port, Large
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 |
|---|---|---|---|---|
| 47065 | Gastric band access port kit | A collection of sterile devices designed to establish a replacement access port for an implanted gastric band of the adjustable type that is invasively inflated. It typically includes access port needles, an access port, an end plug, a connector, and tubing to connect the new port to the existing gastric band. It is typically used when the original port must be removed due to leaks, infection, or contamination. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850007764555 | GS1 |
Customer Contacts
- Phone
- 844-937-7374
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P000008 | 048 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Large |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use if package is damaged and consult instructions for use