FDA UDI
In Commercial Distribution
🇺🇸 United States
ETHICON
DI: 10705036043522
·
Model: EC3D60S
·
ETHICON ENDO-SURGERY, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- ETHICON
- Primary DI
- 10705036043522
- Version / Model
- EC3D60S
- Catalog Number
- EC3D60S
- Company Name
- ETHICON ENDO-SURGERY, LLC
- Labeler DUNS
- 044606982
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-22
- Public Version
- 1
- Public Version Date
- 2025-09-01
- Public Version Status
- New
- Public Device Record Key
- d7b08fe3-23a6-4f98-9c06-7259512758d5
Device Description
ETHICON 4000 STAPLER STRAIGHT 60 STANDARD
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 |
|---|---|---|---|---|
| GAG | Stapler, surgical | General Hospital | 878.4740 | 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 |
|---|---|---|---|---|---|---|
| Package | 20705036043529 | GS1 | BOX | 3 | In Commercial Distribution | |
| Primary | 10705036043522 | GS1 |
Customer Contacts
- Phone
- +1(877)384-4266
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 30 Degrees Celsius