Wide Blade Super Slide Retractor Set
Basic Information
- Brand Name
- Wide Blade Super Slide Retractor Set
- Primary DI
- 10840199501066
- Version / Model
- 7329-400
- Catalog Number
- 7329-400
- 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
- 2021-06-11
- Public Version
- 1
- Public Version Date
- 2021-06-21
- Public Version Status
- New
- Public Device Record Key
- 80212a68-34f8-44da-8a31-a05ef8ba065f
Device Description
Wide Blade Super Slide Retractor Set, Consists of the Following: 1x 7329-410 - Wide Blade Retractor Frame 2x 7329-420 - Wide Blunt Blade 2 x 2 1/8", 2x 7329-422 - Wide Blunt Blade 2 x 3 1/8", 2x 7329-424 - Wide Blunt Blade 2 x 4 1/8", 2x 7329-430 - Wide Blade w/teeth 2 x 4 1/8", 2x 7329-432 - Wide Blade w/teeth 1 3/4 x 4 3/4", 2x 7329-434 - Wide Blade w/teeth 2 1/2 x 5 1/2", 1x 7329-440 - Sacral Blade, Left 2 x 3 1/2", 1x 7329-442 - Sacral Blade, Right 2 x 3 1/2", 1x 7329-444 - Sacral Blade, Left 2 3/4 x 2 1/2", 1x 7329-446 - Sacral Blade, Right 2 3/4 x 2 1/2", 1x 7329-448 - Sacral Blade, Left 3 x 3 ", 1x 7329-450 - Sacral Blade, Right 3 x 3 ", 2x 7329-460 - Unilateral Blade Head, 2x 7329-462 - Unilateral T-Blade 2 1/2", 1x 7329-470 - Wide Blade Retractor Case,
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 | 00840199501069 | GS1 | ||||
| Primary | 10840199501066 | GS1 |
Customer Contacts
- Phone
- 1-805-529-0825
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K881160 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in dry place at room temperature