FDA UDI
In Commercial Distribution
🇺🇸 United States
GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device
DI: 10607915147812
·
Model: C2R12
·
APPLIED MEDICAL RESOURCES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device
- Primary DI
- 10607915147812
- Version / Model
- C2R12
- Company Name
- APPLIED MEDICAL RESOURCES CORPORATION
- Labeler DUNS
- 187129135
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-22
- Public Version
- 1
- Public Version Date
- 2026-04-30
- Public Version Status
- New
- Public Device Record Key
- 134e5bf3-d2a9-44fb-8c1f-c15c4162b3bc
Device Description
The GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device is intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments and maintain insuffiation during laparoscopic-assisted and vaginal gynecological procedures. The device may be used for sentinel pelvic lymph node dissection occurring in the retroperitoneal space. The device is also a conduit for the extraction of specimens.
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
- Yes
- 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 |
|---|---|---|---|---|
| HEW | Culdoscope (And Accessories) | Obstetrics/Gynecology | 884.1640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47432 | Radial surgical retractor seal cap | A sterile device intended to be used with a radial surgical retractor to provide an adjustable membrane that functions as an iris valve seal and access port. It is secured to the retaining latches of the external ring of the inserted retractor whereby the operator can open/close the port by turning the upper seal ring (the action revolves the thin membrane similar to the iris shutter of a camera). It is used to facilitate surgical access while helping to maintain pneumoperitoneum during colorectal, urological, gynaecological, or general abdominal surgical procedures. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10607915147812 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243152 | 000 |