FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Rescue®
DI: 00816849017334
·
Model: DGR-276
·
ENDOCHOICE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- Rescue®
- Primary DI
- 00816849017334
- Version / Model
- DGR-276
- Company Name
- ENDOCHOICE, INC.
- Labeler DUNS
- 014154279
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-09-08
- Public Version
- 5
- Public Version Date
- 2024-01-31
- Public Version Status
- Update
- Public Device Record Key
- d8a05f68-4723-45e5-97a9-9462d977fdd6
- Distribution End Date
- 2024-01-30
Device Description
Rat tooth Grasping Forceps
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
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Primary | 00816849017334 | GS1 | ||||
| Unit of Use | 00816849010236 | GS1 |
Customer Contacts
- Phone
- 888-632-3636
- [email protected]