FDA UDI
In Commercial Distribution
🇺🇸 United States
Sleeve applicator tool
DI: 03665772000053
·
Model: P46732
·
DEX SURGICAL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sleeve applicator tool
- Primary DI
- 03665772000053
- Version / Model
- P46732
- Company Name
- DEX SURGICAL
- Labeler DUNS
- 268845728
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-06
- Public Version
- 1
- Public Version Date
- 2022-05-16
- Public Version Status
- New
- Public Device Record Key
- 0beabf2a-c7d9-41ac-82cc-1979665aed42
Device Description
The Sleeve applicator tool purpose is to help the installation of Protection sleeve 2090-MDS onto the tip of Arm Needle holder B-1301
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58137 | Endoscopic electromechanical surgical system | An assembly of mains electricity (AC-powered) electromechanical devices designed to be used to perform an endoscopic surgical procedure (e.g., laparoscopy) via hand-held rigid endoscopic instruments that have motor-driven articulating and mechanically-operated tips intended to facilitate surgical dexterity. It typically consists of a control unit that provides power via connecting cables to individual handpieces (handles) and several interchangeable endoscopic instruments with tip articulation (e.g., roll, yaw) for performing tissue manipulation, ligation, suturing, and cutting. The system is connected to a visual display unit (VDU) and is typically mounted on a trolley (cart) for mobility. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03665772000053 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191878 | 000 |