FDA UDI
In Commercial Distribution
🇺🇸 United States
Irrigation/Aspiration set 1 spike - with handpiece
DI: 03700512901587
·
Model: RF0401
·
Promepla
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Irrigation/Aspiration set 1 spike - with handpiece
- Primary DI
- 03700512901587
- Version / Model
- RF0401
- Catalog Number
- RF0401
- Company Name
- Promepla
- Labeler DUNS
- 401020409
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-14
- Public Version
- 6
- Public Version Date
- 2019-11-11
- Public Version Status
- Update
- Public Device Record Key
- b013f48b-2b3b-47f2-82e9-fddd1ffab10d
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FHF | System, Evacuator, Fluid | Gastroenterology, Urology | 876.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47625 | Surgical irrigation/aspiration tubing set | A collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03700512921585 | GS1 | Box 2 | 4 | In Commercial Distribution | |
| Package | 03700512911586 | GS1 | Box 1 | 10 | In Commercial Distribution | |
| Primary | 03700512901587 | GS1 |
Customer Contacts
- Phone
- +37797984232
- [email protected]