FDA UDI
In Commercial Distribution
🇺🇸 United States
SharkCut
DI: 08800053401920
·
Model: TSS2850C
·
Techcord co.,Ltd
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SharkCut
- Primary DI
- 08800053401920
- Version / Model
- TSS2850C
- Catalog Number
- TSS2850C
- Company Name
- Techcord co.,Ltd
- Labeler DUNS
- 688890630
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-15
- Public Version
- 1
- Public Version Date
- 2024-04-23
- Public Version Status
- New
- Public Device Record Key
- 40d78f51-5056-4674-b358-18ca26815043
Device Description
Shaver Blade_OD 5.0 WL 230 Cutting Burr Stryker Type
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
- 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 |
|---|---|---|---|---|
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41499 | Arthroscopic shaver system blade, single-use | A cutting device designed for use in a powered arthroscopic shaver system handpiece (not included) for bone and soft-tissue resection during arthroscopic surgery on a joint (e.g., a knee, shoulder, or ankle). It is locked into the handpiece, and typically consists of a small outer tube with a hub and a rotating inner tube with a connector that performs a rotational or reciprocating (back and forth) motion. It is typically made of high-grade stainless steel. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08800053402910 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 08800053401920 | GS1 |
Customer Contacts
- Phone
- +82422210015
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 5.0 | Millimeter | |
| Length | 230 | Millimeter |