FDA UDI
In Commercial Distribution
🇺🇸 United States
K.T.Surgico
DI: KTS1017012
·
Model: 2023
·
K.T.SURGICO
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1200
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Basic Information
- Brand Name
- K.T.Surgico
- Primary DI
- KTS1017012
- Version / Model
- 2023
- Catalog Number
- KTS1017012
- Company Name
- K.T.SURGICO
- Labeler DUNS
- 645493024
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1200
- 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
- cebdaf61-ba7a-4fc7-807f-d4b77daefb15
- Distribution End Date
- 2031-11-30
Device Description
Adson Forcesp Serr. 4.75"
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 |
|---|---|---|---|---|
| 62479 | Surgical soft-tissue manipulation forceps, tweezers-like, single-use | A hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | MASTER04 | HIBCC | Master Box | 1200 | Not in Commercial Distribution | 2023-08-31 |
| Unit of Use | TMS1631412 | HIBCC | ||||
| Primary | KTS1017012 | HIBCC |
Customer Contacts
- Phone
- +6302795000
- [email protected]