Clearview Black Belt Retractor Starter Set
Basic Information
- Brand Name
- Clearview Black Belt Retractor Starter Set
- Primary DI
- 10840199501721
- Version / Model
- 7319-98T
- Catalog Number
- 7319-98T
- 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
- 2021-06-28
- Public Version
- 1
- Public Version Date
- 2021-07-06
- Public Version Status
- New
- Public Device Record Key
- 37b44e79-b497-4850-8342-77b7daae0bd9
Device Description
Clearview Black Belt Retractor Starter Set Consists of the Following: Black Finish Stainless Steel Retractor Frames and Blue Finish Titanium Blades. 1x 7320-22T - Retractor frame Right 1x 7320-30T - Retractor frame Offset 2x 7320-40T - Blade Inserting Angled Clamps 2x 7322-34T - Pronged Blade Ti 34 mm, 2x 7322-40T - Pronged Blade Ti 40 mm, 2x 7322-45T - Pronged Blade Ti 45 mm, 2x 7322-50T - Pronged Blade Ti 50 mm, 2x 7322-55T - Pronged Blade Ti 55 mm, 2x 7322-60T - Pronged Blade Ti 60 mm, 2x 7324-34T - Blunt Blade Ti 34 mm, 2x 7324-40T - Blunt Blade Ti 40 mm, 2x 7324-45T - Blunt Blade Ti 45 mm, 2x 7324-50T - Blunt Blade Ti 50 mm, 2x 7324-55T - Blunt Blade Ti 55 mm, 2x 7324-60T - Blunt Blade Ti 60 mm, 1x 7319-90T - Sterilizing Instrument Case, 1.5 x 11 x 13"
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 | 840199501724 | GS1 | ||||
| Primary | 10840199501721 | 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