FDA UDI
In Commercial Distribution
🇺🇸 United States
MODULAP
DI: 10817428021480
·
Model: 4581
·
ATC TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- MODULAP
- Primary DI
- 10817428021480
- Version / Model
- 4581
- Company Name
- ATC TECHNOLOGIES, INC.
- Labeler DUNS
- 023131605
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2024-12-17
- Public Version
- 1
- Public Version Date
- 2024-12-25
- Public Version Status
- New
- Public Device Record Key
- 2476d9d6-5ee9-43ef-b19e-e80a7256bd47
Device Description
Irrigation/Aspiration J-Hook tip with White Hub, 5mm x 33cm
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
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|
| 64111 | Laparoscopic irrigation cannula | A rigid, hand-operated, single-lumen tube intended to be inserted through a laparoscopic port to provide a conduit for irrigation of body cavities/wounds during a laparoscopic procedure, to facilitate observation. It is not designed to administer parenteral fluids or drugs; it is not designed for surgical aspiration (suction). It is connected via tubing to an appropriate irrigating device (not included). It may be provided with a handle with a valve(s) and hole(s) on its side for the control of irrigation, and/or connection tubing; it is typically made of metal. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 817428021483 | GS1 | ||||
| Primary | 10817428021480 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K983623 | 000 |