FDA UDI
In Commercial Distribution
🇺🇸 United States
Tube set for irrigation, single use
DI: 04056702004477
·
Model: A4054
·
W.O.M. World of Medicine GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Tube set for irrigation, single use
- Primary DI
- 04056702004477
- Version / Model
- A4054
- Company Name
- W.O.M. World of Medicine GmbH
- Labeler DUNS
- 316305242
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-19
- Public Version
- 5
- Public Version Date
- 2019-04-23
- Public Version Status
- Update
- Public Device Record Key
- 622ca7e5-b278-452c-b669-dba47ceeaa0f
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 |
|---|---|---|---|---|
| HIG | Insufflator, Hysteroscopic | Obstetrics/Gynecology | 884.1700 | 2 |
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 | 04056702004484 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 04056702004477 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K022449 | 000 |