FDA UDI
In Commercial Distribution
🇺🇸 United States
Endo Lung
DI: 10884523000788
·
Model: 173051
·
Covidien LP
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Endo Lung
- Primary DI
- 10884523000788
- Version / Model
- 173051
- Company Name
- Covidien LP
- Labeler DUNS
- 058614483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-18
- Public Version
- 4
- Public Version Date
- 2023-03-16
- Public Version Status
- Update
- Public Device Record Key
- b5da5fb1-7604-453a-a774-e10961d3dc3a
Device Description
Clamp
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 |
|---|---|---|---|---|
| GET | MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35524 | Flexible endoscopic tissue manipulation forceps, reusable | A flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20884523000785 | GS1 | CASE | 6 | In Commercial Distribution | |
| Primary | 10884523000788 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K904578 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 12 | Millimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- – 130 Degrees Fahrenheit