FDA UDI
In Commercial Distribution
🇺🇸 United States
Quick Connect Assembly Tool
DI: 00878953000831
·
Model: 72400271
·
AMERICAN MEDICAL SYSTEMS, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Quick Connect Assembly Tool
- Primary DI
- 00878953000831
- Version / Model
- 72400271
- Company Name
- AMERICAN MEDICAL SYSTEMS, INC.
- Labeler DUNS
- 125111448
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 6
- Public Version Date
- 2023-06-06
- Public Version Status
- Update
- Public Device Record Key
- 071aa415-5f3e-48fc-ba8b-524a2732933a
Device Description
Connector Assembly Tool
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
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| JCW | Prosthesis, Penis, Inflatable | Gastroenterology, Urology | 876.3350 | 3 |
| EZY | Device, Incontinence, Mechanical/Hydraulic | Gastroenterology, Urology | 876.5280 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66783 | Urological prosthesis tubing connection crimper | A hand-held manual surgical instrument intended to connect the tubing ends of an implanted urological prosthesis (e.g., inflatable penile prosthesis, urethral sphincter prosthesis) to a connector through compression (crimping). It has a pliers-like design with handles and jaws; the prosthesis is not included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00878953000831 | GS1 | ||||
| Direct Marking | 00878953000527 | GS1 |