FDA UDI
In Commercial Distribution
🇺🇸 United States
KATANA
DI: 10845854035757
·
Model: GU1009EL
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- KATANA
- Primary DI
- 10845854035757
- Version / Model
- GU1009EL
- Catalog Number
- GU1009EL
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-24
- Public Version
- 3
- Public Version Date
- 2024-08-16
- Public Version Status
- Update
- Public Device Record Key
- 3c1a78f2-fc2f-4d1a-af02-460a8bad9529
Device Description
KATANA HIGH STRENGTH SUTURE CUTTER (EXTENDED LENGTH), 210 X 4.0 MM
Device Characteristics
- Single Use
- No
- 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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16224 | Suture cutter, reusable | A dedicated hand-held surgical instrument designed for cutting sutures. It will typically have a protected scalpel-like blade which may be fixed or have a scissors-like cutting action. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 20845854035754 | GS1 | ||||
| Primary | 10845854035757 | GS1 |
Customer Contacts
- Phone
- +1(800)237-0169
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 210 | Millimeter | |
| Outer Diameter | 4 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- KEEP DRY