FDA UDI
In Commercial Distribution
🇺🇸 United States
LINX
DI: 00855106005332
·
Model: LXMC13
·
Torax Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LINX
- Primary DI
- 00855106005332
- Version / Model
- LXMC13
- Catalog Number
- LXMC13
- Company Name
- Torax Medical, Inc.
- Labeler DUNS
- 137949538
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-05-13
- Public Version
- 6
- Public Version Date
- 2021-03-08
- Public Version Status
- Update
- Public Device Record Key
- fa088a9f-2092-47e6-8e55-958107ded789
Device Description
LINX Reflux Management System
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 |
|---|---|---|---|---|
| LEI | Implant, Anti-Gastroesophageal Reflux | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35695 | Gastro-oesophageal antireflux prosthesis | An implantable device introduced into the gastro-oesophageal sphincter to reduce a sliding hiatal hernia, preventing the reflux of gastric contents into the oesophagus. It typically consists of a toroidal, C-shaped elastomer ring filled with a silicone gel that includes a polyester tie to secure the ring around the gastro-oesophageal junction; it is intended for surgical implantation under the diaphragm to hold the lower oesophagus in place as an alternative to traditional surgical fixation of the stomach (i.e., gastropexy) or fundoplication. This GMDN code may reflect old technology. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00855106005332 | GS1 |
Customer Contacts
- Phone
- +1(877)384-4266
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P100049 | 011 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 140 Degrees Fahrenheit