Black Belt Legend All Titanium Basic Retractor System
Basic Information
- Brand Name
- Black Belt Legend All Titanium Basic Retractor System
- Primary DI
- 10840199504401
- Version / Model
- 7320-00PT
- Catalog Number
- 7320-00PT
- 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
- 2022-10-31
- Public Version
- 1
- Public Version Date
- 2022-11-08
- Public Version Status
- New
- Public Device Record Key
- 247fc427-e4cc-47cf-8a0b-ac7d3cd4d780
Device Description
Black Belt Legend All Titanium Basic Retractor System, Consists of the Following: 1x 7320-22P - Korpectomy Ti Retractor frame Right 1x 7320-20P - Ti Retractor frame Left 1x 7320-30P - Ti Retractor frame Offset 1x 7320-35P - Black Belt Legend Screwdriver 2x 7320-40M - Ti Blade Inserting Clamps 2x 7322-34M - Pronged Ti Blade 34mm, 2x 7322-40M - Pronged Ti Blade 40mm, 2x 7322-45M - Pronged Ti Blade 45mm, 2x 7322-50M - Pronged Ti Blade 50mm, 2x 7322-55M - Pronged Ti Blade 55mm, 2x 7322-60M - Pronged Ti Blade 60mm, 2x 7322-70M - Pronged Ti Blade 70mm, 2x 7324-34M - Blunt Ti Blade 34mm, 2x 7324-40M - Blunt Ti Blade 40mm, 2x 7324-45M - Blunt Ti Blade 45mm, 2x 7324-50M - Blunt Ti Blade 50mm, 2x 7324-55M - Blunt Ti Blade 55mm, 2x 7324-60M - Blunt Ti Blade 60mm, 2x 7324-70M - Blunt Ti Blade 70mm, 4x 7326-40M - Two-Level Ti Blade Pronged 40mm, 4x 7326-47M - Two-Level Ti Blade Pronged 47mm, 4x 7326-55M - Two-Level Ti Blade Pronged 55mm, 2x 7328-40M - Two-Level Ti Blade Blunt 40mm, 2x 7328-47M - Two-Level Ti Blade Blunt 47mm, 2x 7328-55M - Two-Level Ti Blade Blunt 55mm, 1x 7320-90M - Sterilizing Instrument Case with silicone pads
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 |
|---|---|---|---|---|
| 45182 | Self-retaining surgical retractor, reusable | A hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 00840199504404 | GS1 | ||||
| Primary | 10840199504401 | 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