FDA UDI
In Commercial Distribution
🇺🇸 United States
K.T.Surgico
DI: KTS1222112
·
Model: 2023
·
K.T.SURGICO
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
800
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Basic Information
- Brand Name
- K.T.Surgico
- Primary DI
- KTS1222112
- Version / Model
- 2023
- Catalog Number
- KTS1222112
- Company Name
- K.T.SURGICO
- Labeler DUNS
- 645493024
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 800
- Record Status
- Published
- Publish Date
- 2024-02-20
- Public Version
- 1
- Public Version Date
- 2024-02-28
- Public Version Status
- New
- Public Device Record Key
- 819c5247-09e1-472e-a264-960d9ee60860
- Distribution End Date
- 2031-11-30
Device Description
Mosquito Forcep CVD 5"
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61478 | Surgical soft-tissue manipulation forceps, scissors-like, single-use | A hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues; it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | MASTER02 | HIBCC | Master Box | 800 | Not in Commercial Distribution | 2023-08-30 |
| Unit of Use | TMS1732112 | HIBCC | ||||
| Primary | KTS1222112 | HIBCC |
Customer Contacts
- Phone
- +6302795000
- [email protected]