FDA UDI
In Commercial Distribution
🇺🇸 United States
EndoTGrasper
DI: 00816207020334
·
Model: ET2021
·
ENDO-THERAPEUTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- EndoTGrasper
- Primary DI
- 00816207020334
- Version / Model
- ET2021
- Catalog Number
- ET2021
- Company Name
- ENDO-THERAPEUTICS, INC.
- Labeler DUNS
- 825239189
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 7
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- e2e5b8c5-26e9-464c-b81b-8f4674bad682
Device Description
Endoscopic retrieval 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
- Yes
- 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 |
|---|---|---|---|---|
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33199 | Flexible endoscopic tissue manipulation forceps, single-use | 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 single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10816207020331 | GS1 | box | 10 | In Commercial Distribution | |
| Primary | 00816207020334 | GS1 |
Customer Contacts
- Phone
- 844-400-3636
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K800972 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Min Channel 2.8 mm | ||
| Outer Diameter | 2.4 | Millimeter | |
| Length | 150 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry