FDA UDI
In Commercial Distribution
🇺🇸 United States
GelPOINT® Advanced Access Platform
DI: 00607915125325
·
Model: CNGL2
·
APPLIED MEDICAL RESOURCES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- GelPOINT® Advanced Access Platform
- Primary DI
- 00607915125325
- Version / Model
- CNGL2
- Company Name
- APPLIED MEDICAL RESOURCES CORPORATION
- Labeler DUNS
- 187129135
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-03-25
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 3d13083b-32b2-437f-bb40-1605c969b19d
Device Description
Access platform for minimally invasive surgery
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 |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38456 | Laparoscopic multi-instrument access port, single-use | A sterile sleeve assembly made of plastic materials intended to retract a small abdominal incision to allow multiple laparoscopic instruments to pass into the abdomen at the same time during a laparoscopic procedure. It will typically have an introducer that creates the abdominal incision (but is not used in cases where the surgeon chooses to make the incision), and a valve component that maintains the pneumoperitoneum established for the surgical procedure. It allows for the introduction of multiple instruments and/or a camera port, and removal of larger specimens during minimally-invasive laparoscopic surgery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10607915125322 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 00607915125325 | GS1 |
Customer Contacts
- Phone
- 1.949.713.8300
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 1.5-7 cm incisions |