FDA UDI
In Commercial Distribution
🇺🇸 United States
LAP-BAND® System Access Port Needle, 20G x 51 mm (2 in.)
DI: 10850007764323
·
Model: B-20302-10
·
Reshape Lifesciences Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- LAP-BAND® System Access Port Needle, 20G x 51 mm (2 in.)
- Primary DI
- 10850007764323
- Version / Model
- B-20302-10
- Catalog Number
- B-20302-10
- Company Name
- Reshape Lifesciences Inc.
- Labeler DUNS
- 022894714
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2021-04-01
- Public Version
- 5
- Public Version Date
- 2024-01-19
- Public Version Status
- Update
- Public Device Record Key
- 9f9f6e1f-0ac5-445f-8174-1e00bf56dc0f
Device Description
LAP-BAND® Access Port Needle 2 inch Pouch
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| 17180 | Subcutaneous infusion/injection port needle | A sterile, sharp bevel-edged, hollow tubular metal instrument intended to be attached to a syringe and designed for the therapeutic injection or infusion of medicinal substances directly beneath the skin layer. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10850007764323 | GS1 | ||||
| Previous | 10811955020428 | GS1 | ||||
| Unit of Use | 00850007764326 | GS1 |
Customer Contacts
- Phone
- 844-937-7374
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P000008 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use if package is damaged and consult instructions for use