Multi Level Black Belt Set
Basic Information
- Brand Name
- Multi Level Black Belt Set
- Primary DI
- 10840199503558
- Version / Model
- 7325-50
- Catalog Number
- 7325-50
- Company Name
- KOROS U.S.A., INC.
- Labeler DUNS
- 007928633
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-03
- Public Version
- 1
- Public Version Date
- 2021-06-11
- Public Version Status
- New
- Public Device Record Key
- 3a28b4fa-2bcc-4442-a7fb-23487e390b49
Device Description
Multi Level Black Belt Set Consists of the Following: 1x 7325-51 - Retractor, Right, 1x 7325-52 - Retractor, Left, 1x 7325-53 - Triple Blade Retractor Right for wide blades, 1x 7325-54 - Triple Blade Retractor Left for wide blades, 1x 7325-58 - Depth Gauge, 4x 7325-60 - 55 mm standard width blunt blade colored anodized, 4x 7325-61 - 60 mm standard width blunt blade colored anodized, 4x 7325-62 - 65 mm standard width blunt blade colored anodized, 4x 7325-63 - 70 mm standard width blunt blade colored anodized, 4x 7325-70 - 55 mm standard width prong blade colored anodized, 4x 7325-71 - 60 mm standard width prong blade colored anodized, 4x 7325-72 - 65 mm standard width prong blade colored anodized, 4x 7325-73 - 70 mm standard width prong blade colored anodized, 4x 7325-84 - 55 mm x 40 mm wide blunt blade colored anodized, 4x 7325-81 - 60 mm x 40 mm wide blunt blade colored anodized, 4x 7325-82 - 65 mm x 40 mm wide blunt blade colored anodized, 4x 7325-83 - 70 mm x 40 mm wide blunt blade colored anodized, 4x 7325-90 - 55 mm x 40 mm wide prong blade colored anodized, 4x 7325-91 - 60 mm x 40 mm wide prong blade colored anodized, 4x 7325-92 - 65 mm x 40 mm wide prong blade colored anodized, 4x 7325-93 - 70 mm x 40 mm wide prong blade colored anodized, 2x 7320-40 - Black Belt Blade Inserter Clamp, 1x 7325-59 - Instrument Tray
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| GZT | Retractor, Self-Retaining, For Neurosurgery | Neurology | 882.4800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46774 | Surgical retractor/retraction system blade, reusable | A distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 00840199503551 | GS1 | ||||
| Primary | 10840199503558 | GS1 |
Customer Contacts
- Phone
- 1-805-529-0825
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K935529 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in dry place at room temperature