FDA UDI
In Commercial Distribution
🇺🇸 United States
GelPOINT V-Path
DI: 00607915138493
·
Model: C2A15
·
APPLIED MEDICAL RESOURCES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- GelPOINT V-Path
- Primary DI
- 00607915138493
- Version / Model
- C2A15
- Company Name
- APPLIED MEDICAL RESOURCES CORPORATION
- Labeler DUNS
- 187129135
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-17
- Public Version
- 3
- Public Version Date
- 2023-03-07
- Public Version Status
- Update
- Public Device Record Key
- deb1c0e6-6dfe-4460-8a52-5647c14723b6
Device Description
Transvaginal Access Platform
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 |
|---|---|---|---|---|---|---|
| Package | 10607915138490 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 00607915138493 | GS1 | ||||
| Package | 10607915140516 | GS1 | 1 | In Commercial Distribution | ||
| Package | 10607915145658 | GS1 | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-949-713-8300
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 7 cm |