FDA UDI
In Commercial Distribution
🇺🇸 United States
LiNA OperaScope™ Rat Tooth Alligator Grasper
DI: 05708265012466
·
Model: OP-GRA-6
·
Lina Medical ApS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- LiNA OperaScope™ Rat Tooth Alligator Grasper
- Primary DI
- 05708265012466
- Version / Model
- OP-GRA-6
- Catalog Number
- OP-GRA-6
- Company Name
- Lina Medical ApS
- Labeler DUNS
- 305088619
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-04
- Public Version
- 1
- Public Version Date
- 2020-09-14
- Public Version Status
- New
- Public Device Record Key
- 591f68e2-5f99-4947-bc37-a27008bbe1e0
Device Description
Rat Tooth Alligator Grasper intended for hysteroscopy and cystoscopy. Minimum channel diameter: Ø2.0mm.
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
- Yes
- 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 |
|---|---|---|---|---|
| HTD | Forceps | General, Plastic Surgery | 878.4800 | 1 |
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 | 05708265012473 | GS1 | box | 6 | In Commercial Distribution | |
| Primary | 05708265012466 | GS1 |
Customer Contacts
- Phone
- +48 612222149
- [email protected]