FDA UDI
In Commercial Distribution
🇺🇸 United States
Irrigation Tubing Set for ElcoMED SA 200/ SA 200C 3.8 m
DI: 04251783104119
·
Model: 04365100
·
Assamed GmbH - Medizinbedarf
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Irrigation Tubing Set for ElcoMED SA 200/ SA 200C 3.8 m
- Primary DI
- 04251783104119
- Version / Model
- 04365100
- Company Name
- Assamed GmbH - Medizinbedarf
- Labeler DUNS
- 319354346
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-29
- Public Version
- 1
- Public Version Date
- 2023-04-06
- Public Version Status
- New
- Public Device Record Key
- 8b6f993b-516c-4adb-953f-2f3c26f3ddff
Device Description
Irrigation Tubing Set for ElcoMED SA 200/ SA 200C 3.8 m
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
- 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 |
|---|---|---|---|---|
| GBX | Catheter, Irrigation | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46102 | Surgical irrigation tubing set, single-use | A collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. 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 | 14251783104116 | GS1 | 6 | In Commercial Distribution | ||
| Primary | 04251783104119 | GS1 | ||||
| Package | 24251783104113 | GS1 | 180 | In Commercial Distribution |
Customer Contacts
- Phone
- +49(0)682681155
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 3.8 | Meter |