FDA UDI
In Commercial Distribution
🇺🇸 United States
Transport Endoscopic Access Device
DI: 00860009064706
·
Model: Transport Retroflex
·
Usgi Medical, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Transport Endoscopic Access Device
- Primary DI
- 00860009064706
- Version / Model
- Transport Retroflex
- Catalog Number
- 118180
- Company Name
- Usgi Medical, Inc.
- Labeler DUNS
- 112331090
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-20
- Public Version
- 1
- Public Version Date
- 2022-12-28
- Public Version Status
- New
- Public Device Record Key
- 0ab4728a-5a30-4fee-882b-49cbac541603
Device Description
Transport Endoscopic Access Device
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
- 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 |
|---|---|---|---|---|
| ODB | Endoscopic Contamination Prevention Sheath | Gastroenterology, Urology | 876.1500 | 2 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60438 | Multichannel gastrointestinal endoscopic guide, steerable | A sterile, steerable, multi-luminal, flexible tube intended to function as a housing for a compatible flexible endoscope and endoscopic tool(s), to facilitate introduction of the endoscope, and provide independent working channels (i.e., not through the endoscope) for the flexible endoscopic tool(s) during procedures of the upper gastrointestinal (GI) tract (e.g., placement of tissue anchors). It includes proximal ports and controls to steer the distal end, and may assist in the repeated advancement and withdrawal of the endoscope or endoscopic devices. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860009064706 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K072405 | 000 |