FDA UDI
In Commercial Distribution
🇺🇸 United States
McCarus-Volker FORNISEE® SYSTEM
DI: 00850200006223
·
Model: 110035
·
LSI Solutions, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- McCarus-Volker FORNISEE® SYSTEM
- Primary DI
- 00850200006223
- Version / Model
- 110035
- Catalog Number
- 110035
- Company Name
- LSI Solutions, Inc.
- Labeler DUNS
- 603420183
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 6
- Public Version Date
- 2022-11-10
- Public Version Status
- Update
- Public Device Record Key
- ab81cbb6-c266-4046-9bb3-4ed4ee49c128
Device Description
FS-35 DEVICE - (35mm Cervical Cup)
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
- 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 |
|---|---|---|---|---|
| LKF | Cannula, manipulator/injector, uterine | Obstetrics/Gynecology | 884.4530 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58051 | Uterine manipulator, single-use | A sterile, hand-held manual surgical instrument designed to atraumatically mechanically manipulate the position of the uterus during a gynaecological intervention (e.g., laparoscopy) to enable uterine control and improved visibility of the pelvic anatomy, as well as for chromotubation. The device typically consists of a long shaft with an inflatable balloon at the distal end which is transcervically placed inside the uterus and inflated, via a connected syringe (sometimes included), with sterile saline or air; once inflated, the operator can manipulate the uterus. Deflation is a reverse of the inflation process. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850200006220 | GS1 | Case | 6 | In Commercial Distribution | |
| Primary | 00850200006223 | GS1 |
Customer Contacts
- Phone
- +1(866)575-3493
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111014 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 35 | Millimeter |