FDA UDI
In Commercial Distribution
🇺🇸 United States
Omni 5 Fr. Seal Cap
DI: 15420045513839
·
Model: 60-5FR
·
Hologic, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Omni 5 Fr. Seal Cap
- Primary DI
- 15420045513839
- Version / Model
- 60-5FR
- Catalog Number
- 60-5FR
- Company Name
- Hologic, Inc.
- Labeler DUNS
- 018925968
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-28
- Public Version
- 3
- Public Version Date
- 2024-01-19
- Public Version Status
- Update
- Public Device Record Key
- a22f9730-1b6a-453b-abb8-4bb28bef05d9
Device Description
The Omni™ 5 Fr. Seal Caps are an accessory to the Hologic Hysteroscopes and are used to prevent distension fluid leakage from the proximal ends of the removable outflow channels.
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
- Yes
- 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 |
|---|---|---|---|---|
| HIH | HYSTEROSCOPE (AND ACCESSORIES) | Obstetrics/Gynecology | 884.1690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60650 | Endoscope working-channel seal | A sterile device intended to be fitted over the working channel access port of an endoscope to minimize leakage of liquids and gases through the working channel, while permitting entry of endoscopic devices. It is typically a small plastic Luer attachment with an intraluminal seal. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15420045513839 | GS1 | ||||
| Package | 45420045513847 | GS1 | CARTON | 32 | In Commercial Distribution | |
| Package | 35420045513840 | GS1 | CARTON | 1 | In Commercial Distribution | |
| Package | 25420045513843 | GS1 | BOX | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)442-9892
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142029 | 000 |