FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SteriGear
DI: 00618125155477
·
Model: 27304
·
TIDI PRODUCTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- SteriGear
- Primary DI
- 00618125155477
- Version / Model
- 27304
- Catalog Number
- 27304
- Company Name
- TIDI PRODUCTS, LLC
- Labeler DUNS
- 063519193
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-27
- Public Version
- 3
- Public Version Date
- 2023-12-04
- Public Version Status
- Update
- Public Device Record Key
- 370823e8-7cea-472f-80e3-dea3ce0e28f3
- Distribution End Date
- 2023-11-30
Device Description
SteriGear Urology Drain Bags Vinyl Sterile Fits Uroview 2000/2500 20 per Case
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| MMZ | Table, Cystometric, Electric | Gastroenterology, Urology | 876.4890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61676 | Urological fluid funnel, sterile | A sterile device designed to be attached to a urological operating table (e.g., to a hoop frame) to channel fluids associated with a urological examination or surgery (i.e., body and irrigation fluids) from the table to an appropriate container, surgical suction system, or floor drain. It is typically constructed of flexible plastic material in the shape of funnel; it may include a filter, to trap tissue debris (e.g., urinary stones), and tubing. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10618125155474 | GS1 | Case | 20 | Not in Commercial Distribution | 2023-11-30 |
| Primary | 00618125155477 | GS1 | ||||
| Previous | 01618125155476 | GS1 |