FDA UDI
In Commercial Distribution
🇺🇸 United States
endomina platform
DI: 05425029282018
·
Model: endomina platform
·
Endo Tools Therapeutics
Product Codes
1
GMDN Terms
1
Identifiers
6
Pkg Device Count
1
Basic Information
- Brand Name
- endomina platform
- Primary DI
- 05425029282018
- Version / Model
- endomina platform
- Company Name
- Endo Tools Therapeutics
- Labeler DUNS
- 400000750
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-19
- Public Version
- 3
- Public Version Date
- 2023-04-06
- Public Version Status
- Update
- Public Device Record Key
- a1ad52c8-daf2-450d-94bd-27e09cc8c4f7
Device Description
endomina platform primary packaging (x1)
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 Safe
- 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 |
|---|---|---|---|---|
| OCW | Endoscopic Tissue Approximation Device | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46687 | Endoscopic overtube, single-use | A tubular device intended to be used in combination with a compatible flexible endoscope to aid in endoscopic insertions and to secure a pathway for multiple endoscopic intubations during diagnostic and therapeutic endoscopic procedures (e.g., upper and/or lower gastrointestinal (GI) tract endoscopy). It is a non-steerable, typically single lumen tube constructed of plastic; some types may be "shape locked" into a desired configuration or form to assist in the repeated advancement and withdrawal of the endoscope (e.g., for the removal of multiple polyps and/or foreign bodies). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05425029282117 | GS1 | secondary packaging | 1 | In Commercial Distribution | |
| Primary | 05425029282018 | GS1 | ||||
| Package | 05425029282339 | GS1 | Tertiary packaging | 4 | In Commercial Distribution | |
| Package | 05425029282940 | GS1 | Pallet | 4 | In Commercial Distribution | |
| Package | 05425029282957 | GS1 | Pallet | 12 | In Commercial Distribution | |
| Package | 05425029282926 | GS1 | Pallet | 16 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211309 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 30 Degrees Celsius