FDA UDI
In Commercial Distribution
🇺🇸 United States
Endolumik
DI: G461EGCT400
·
Model: EGCT40
·
Endolumik, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Endolumik
- Primary DI
- G461EGCT400
- Version / Model
- EGCT40
- Company Name
- Endolumik, Inc.
- Labeler DUNS
- 117601339
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-15
- Public Version
- 1
- Public Version Date
- 2023-05-23
- Public Version Status
- New
- Public Device Record Key
- cc6e1506-46b4-4a6a-a174-f2bdb439a562
Device Description
Endolumik Gastric Calibration Tube, 40F
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FAT | Bougie, Esophageal, And Gastrointestinal, Gastro-Urology | Gastroenterology, Urology | 876.5365 | 2 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44686 | Gastric calibration tube | A thin, flexible, hollow cylinder with an inflatable balloon at the distal end designed to be inserted into a patient's stomach through the mouth and oesophagus to create and size a gastric pouch typically for a bariatric gastric surgical procedure (e.g., sleeve gastrectomy, gastric banding). The proximal end may include a check valve and connects to a syringe, typically included, intended to inflate the balloon to a predetermined volume; fluid suction/irrigation ports are provided at the distal end. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G461EGCT400 | HIBCC | ||||
| Package | G461EGCT401 | HIBCC | Cardboard box | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- 304-207-0072
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Circumference | 41.9 | Millimeter |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 500 – 1060 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 140 Degrees Fahrenheit