FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Suction Irrigation Cartridge Set
DI: 00607915127589
·
Model: C7100
·
APPLIED MEDICAL RESOURCES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Suction Irrigation Cartridge Set
- Primary DI
- 00607915127589
- Version / Model
- C7100
- Company Name
- APPLIED MEDICAL RESOURCES CORPORATION
- Labeler DUNS
- 187129135
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-18
- Public Version
- 6
- Public Version Date
- 2019-04-23
- Public Version Status
- Update
- Public Device Record Key
- 2323e1e5-7602-439e-bd81-71bc3ef5bbd4
- Distribution End Date
- 2018-04-19
Device Description
Cartridge set with probe.
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 |
|---|---|---|---|---|
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | General, Plastic Surgery | 878.4780 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47625 | Surgical irrigation/aspiration tubing set | A collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). 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 |
|---|---|---|---|---|---|---|
| Package | 10607915127586 | GS1 | 12 | Not in Commercial Distribution | 2018-04-19 | |
| Primary | 00607915127589 | GS1 |
Customer Contacts
- Phone
- 1.949.713.8300
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 5 | Millimeter | |
| Length | 33 | Centimeter |