FDA UDI
In Commercial Distribution
🇺🇸 United States
Surgyco
DI: 10850053289801
·
Model: STF00865
·
Surgyco LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Surgyco
- Primary DI
- 10850053289801
- Version / Model
- STF00865
- Company Name
- Surgyco LLC
- Labeler DUNS
- 118768538
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2024-12-20
- Public Version
- 1
- Public Version Date
- 2024-12-30
- Public Version Status
- New
- Public Device Record Key
- 35ab3cf6-feb9-44e1-bb96-f96d55dbdbcf
Device Description
FOLEY CATHETER 2 WAYS, 5CC 12FR SILICONE COATED
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EZL | Catheter, Retention Type, Balloon | Gastroenterology, Urology | 876.5130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47017 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20850053289808 | GS1 | Case | 500 | In Commercial Distribution | |
| Primary | 10850053289801 | GS1 | ||||
| Unit of Use | 00850053289804 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K082815 | 000 |