FDA UDI
In Commercial Distribution
🇺🇸 United States
Sizer
DI: 00878953005386
·
Model: 720153-01
·
AMERICAN MEDICAL SYSTEMS, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sizer
- Primary DI
- 00878953005386
- Version / Model
- 720153-01
- Company Name
- AMERICAN MEDICAL SYSTEMS, INC.
- Labeler DUNS
- 125111448
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-31
- Public Version
- 6
- Public Version Date
- 2019-05-07
- Public Version Status
- Update
- Public Device Record Key
- 388a37a0-81da-439a-86f7-91043717a38c
Device Description
1 Sizer 9.5 mm Diameter (00878953000497), 1 Sizer 12 mm Diameter (00878953000503)
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
- 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 |
| FHW | Device, Impotence, Mechanical/Hydraulic | Gastroenterology, Urology | 876.3350 | 3 |
| FAE | Prosthesis, Penile | Gastroenterology, Urology | 876.3630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44796 | Medical ruler, reusable | A small straight-edged strip intended to be used to measure the length of internal or external anatomy, devices or instruments in a clinical setting. It is marked in units of length (i.e., inches, millimetres and/or centimetres), and may be an independent bendable strip applied to measured surfaces or a strip incorporated into a form convenient for measuring specific devices (e.g., screws). It is not dedicated to wound measurements. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00878953005386 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 12 | Millimeter | |
| Outer Diameter | 9.5 | Millimeter |