FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NA
DI: 04055207048627
·
Model: 4170954
·
Richard Wolf GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- NA
- Primary DI
- 04055207048627
- Version / Model
- 4170954
- Catalog Number
- 4170.954
- Company Name
- Richard Wolf GmbH
- Labeler DUNS
- 315304071
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2017-06-28
- Public Version
- 9
- Public Version Date
- 2024-02-29
- Public Version Status
- Update
- Public Device Record Key
- 057ff1d2-a2c5-425d-a83a-87222338b043
- Distribution End Date
- 2024-01-01
Device Description
SUCTION/IRRIGATION TUBE SET L 3M PVC, PACK=10 PCS, with 3mm female Luer lock, for suction irrigation handle 8385.901, sterile, for single use
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
- No
- 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 |
|---|---|---|---|---|
| GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | General, Plastic Surgery | 878.4400 | 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 |
|---|---|---|---|---|---|---|
| Primary | 04055207048627 | GS1 | ||||
| Unit of Use | 04055207049525 | GS1 |
Customer Contacts
- Phone
- +497043350
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 3 | Meter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 70 Percent (%) Relative Humidity