FDA UDI
In Commercial Distribution
🇺🇸 United States
Clover Retractor Set
DI: 10840199543691
·
Model: 7332-65
·
KOROS U.S.A., INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Clover Retractor Set
- Primary DI
- 10840199543691
- Version / Model
- 7332-65
- Catalog Number
- 7332-65
- 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
- a6d42363-b16e-4874-896f-19f58b5011da
Device Description
Clover Retractor Set Consists of the Following: 1 x 7332-66, 4 x 7332-68, 2 x 7332-71, 1 x 7332-72,, 1 x 7332-73D, 1 x 7332-74D, 1 x 7332-75D, 1 x 7332-76D, 1 x 7332-86D, 1 x 7332-89D, 1 x 7332-77D, 1 x 7332-78, 2 x 7332-79, 2 x 7332-81, 2 x 7332-82, 2 x 7332-84, 1 x 7332-91, 1 x 7332-93, 1 x 7332-97, 1 x 7332-98, 2 x 7225-54B, 1 x 7233-54, 1 x 7233-56, 2 x 7218-18, 1 x 7042-42I, 1 x 7233-62, 1 x 7233-64, 1 x 7233-66, 1 x 7338-05, 1 x 7230-60, 1 x 7230-62, 1 x 7233-83, 1 x 7233-87& 1 x 7233-69
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
- 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 |
|---|---|---|---|---|
| GAD | Retractor | General, Plastic Surgery | 878.4800 | 1 |
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 | 00840199543694 | GS1 | ||||
| Primary | 10840199543691 | GS1 |
Customer Contacts
- Phone
- 1-805-529-0825
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 9x12mm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in dry place at room temperature