SURGYCO
- Primary DI
- 00850053289101
- Brand
- SURGYCO
- Company
- Surgyco LLC
- Model
- ST001010
- Device description
- Pre-Connected Foley Catheter Tray 18FR.
- Published
- 2023-12-15
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| FCN | Urinary Drainage Collection Kit, For Indwelling Catheter |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| FCN | Urinary Drainage Collection Kit, For Indwelling Catheter | Gastroenterology, Urology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10850053289108 | Primary | GS1 | 0 | |
| 00850053289101 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10850053289108 | 10850053289108 | | |
| 00850053289101 | 00850053289101 | 850053289101 | 0850053289101 |
GMDN Terms
| Term | Definition |
|---|
| General-purpose syringe, single-use | A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device. |
Regulatory Flags
- DUNS number
- 118768538
- Device count
- 10
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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|---|
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| 00850053289095 | SURGYCO | Surgyco LLC | FCN | 2023-12-15 |
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| 50885380176713 | Dover | Cardinal Health, Inc. | FCN | 2021-03-17 |
| 50885380176720 | Dover | Cardinal Health, Inc. | FCN | 2021-03-17 |
| 50885380176737 | Dover | Cardinal Health, Inc. | FCN | 2021-03-17 |
| 10851616002028 | SteriGear | Sterigear, LLC | FCN | 2020-11-17 |
| 10851616002035 | SteriGear | Sterigear, LLC | FCN | 2020-11-17 |
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