ECHELON FLEX
Basic Information
- Brand Name
- ECHELON FLEX
- Primary DI
- 10705036015352
- Version / Model
- PSEE45A
- Catalog Number
- PSEE45A
- Company Name
- ETHICON ENDO-SURGERY, LLC
- Labeler DUNS
- 044606982
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-22
- Public Version
- 3
- Public Version Date
- 2019-10-16
- Public Version Status
- Update
- Public Device Record Key
- da74327e-f994-4b3d-be9e-d46459cc7bcb
Device Description
The ECHELON FLEX Powered Plus Articulating Endoscopic Linear Cutters are sterile, single patient use instruments that simultaneouslycut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The ECHELON FLEX 45 Powered Plusinstruments have a staple line that is approximately 45 mm long and a cut line that is approximately 42 mm long. The shaft can rotate freelyin both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate lateral access to the operativesite.The instruments are packaged with a primary lithium battery pack that must be installed prior to use. There are specific requirements fordisposing of the battery pack. Refer to the Battery Pack Disposal section.The instruments are packaged without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple legpoints during shipping and transportation. The instruments’ lock-out feature is designed to prevent a used or improperly installed reloadfrom being refired or an instrument from being fired without a reload.
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 |
|---|---|---|---|---|
| GDW | STAPLE, IMPLANTABLE | General, Plastic Surgery | 878.4750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58483 | Endoscopic motorized cutting stapler, single-use | A sterile, hand-held, battery-powered surgical instrument designed to be used during endoscopic surgical procedures for the expeditious transection and resection of tissues and the creation of anastomoses; it may also be used during open surgery. The device is intended to mechanically cut the tissue and simultaneously apply surgical staples to the resulting sides of the cut line, with power from a motor in the handle. This device is typically loaded with staples and may be pistol-like in design. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10705036015352 | GS1 | ||||
| Package | 20705036015359 | GS1 | BOX | 3 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(877)384-4266
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -22 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 80 Percent (%) Relative Humidity