FDA UDI
In Commercial Distribution
🇺🇸 United States
Uro-EZDilate KIT 18Fr (6mm) x 4cm URETERAL BALLOON DILATION CATHETER
DI: 00821925033139
·
Model: BURS0604K
·
Gyrus Acmi, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Uro-EZDilate KIT 18Fr (6mm) x 4cm URETERAL BALLOON DILATION CATHETER
- Primary DI
- 00821925033139
- Version / Model
- BURS0604K
- Company Name
- Gyrus Acmi, Inc.
- Labeler DUNS
- 007198742
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-05
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 55d28766-be38-4fe5-9be0-256fb25d8e5b
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KOE | DILATOR, URETHRAL | Gastroenterology, Urology | 876.5520 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10737 | Ureteral dilatation catheter | A flexible tube designed to be inserted into the ureters exclusively to increase the ureteral lumen by eliminating areas of narrowing (i.e., strictures). It is typically made of plastic and may have a special tip (e.g., olive) or an inflatable hydraulic balloon at its tip for dilating. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00821925033139 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132181 | 000 |