Flexible Overtube
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Basic Information
- Brand Name
- Flexible Overtube
- Primary DI
- 04545499070098
- Version / Model
- MD-48719
- Company Name
- SB-KAWASUMI LABORATORIES, INC.
- Labeler DUNS
- 690625850
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-23
- Public Version
- 3
- Public Version Date
- 2022-05-30
- Public Version Status
- Update
- Public Device Record Key
- cc9e2b9a-a53e-4d78-92a7-72be66e976f0
Device Description
Flexible Overtube provides an access for repeated insertion and withdrawal of an endoscope for tissue or foreign body retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations. Flexible Overtube consists of an overtube with a coiled stainless steel skelton, a detachable seal unit for an endoscope, and a detachable mouthpiece for a patient. The steel skelton of the overtube prevents the overtube from being bent and collapsed while keeping flexibility of the overtube. The detachable seal unit named “AD rubber unit” can be attached to the proximal end of the overtube to maintain insufflation and minimize leakage of air during endoscopic treatment. The overtube can be locked with the mouthpiece to maintain the proper placement of the overtube.
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 |
|---|---|---|---|---|
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 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 |
|---|---|---|---|---|---|---|
| Primary | 04545499070098 | GS1 | ||||
| Package | 24545499070092 | GS1 | Box | 1 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 205 | Millimeter | |
| Outer Diameter | 19 | Millimeter |