FDA UDI
In Commercial Distribution
🇺🇸 United States
Locking device
DI: 03700512905516
·
Model: RCG10992ST162
·
Promepla
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Locking device
- Primary DI
- 03700512905516
- Version / Model
- RCG10992ST162
- Catalog Number
- RCG10992ST162
- Company Name
- Promepla
- Labeler DUNS
- 401020409
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-23
- Public Version
- 1
- Public Version Date
- 2019-09-02
- Public Version Status
- New
- Public Device Record Key
- 57bed72b-0e46-4a9f-b4d2-2d6e682cc5f7
Device Description
The Locking device is an adapter for holding and securing the position of a device with an outside diameter of 2-3 Fr that is inserted through a device with demale luer connector used during interventional of diagnostic procedures.
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
- 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 |
|---|---|---|---|---|
| KGZ | Accessories, Catheter | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46115 | General-purpose catheter connector, sterile | A small sterile device intended to create a mechanical union between a catheter and an external device (non-dedicated) typically via a Luer connection; it has an intended use profile that is not dedicated to a specific type of catheter (i.e., can be applied to catheters specific to different anatomical sites and body fluids). It may be used to permit catheter insertion and/or manipulation, and/or to facilitate delivery or extraction of substances through the catheter lumen. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03700512925514 | GS1 | Box 2 | 16 | In Commercial Distribution | |
| Package | 03700512915515 | GS1 | Box 1 | 12 | In Commercial Distribution | |
| Primary | 03700512905516 | GS1 |