FDA UDI
In Commercial Distribution
🇺🇸 United States
AccuMedx
DI: 00850059707487
·
Model: AMSI-33S
·
Accumedx, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- AccuMedx
- Primary DI
- 00850059707487
- Version / Model
- AMSI-33S
- Company Name
- Accumedx, LLC
- Labeler DUNS
- 096236324
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-23
- Public Version
- 1
- Public Version Date
- 2024-01-31
- Public Version Status
- New
- Public Device Record Key
- 3c5741c5-6b7f-43c1-be0d-98123c865191
Device Description
5mm x 330mm Smoke Evacuation Stainless Steel Probe, 300cm Soft Tube Suction Irrigation System
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46102 | Surgical irrigation tubing set, single-use | A collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850059707487 | GS1 | ||||
| Package | 00850059707494 | GS1 | Inner Pack | 10 | In Commercial Distribution | |
| Package | 00850059707500 | GS1 | Case | 2 | In Commercial Distribution |