FDA UDI
In Commercial Distribution
🇺🇸 United States
Riptide Collection Canister with Intermediate Tubing
DI: 00763000981327
·
Model: LMT-RCT
·
Micro Therapeutics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Riptide Collection Canister with Intermediate Tubing
- Primary DI
- 00763000981327
- Version / Model
- LMT-RCT
- Company Name
- Micro Therapeutics, Inc.
- Labeler DUNS
- 826110710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-31
- Public Version
- 1
- Public Version Date
- 2025-11-10
- Public Version Status
- New
- Public Device Record Key
- 410b43ac-a3bd-4f13-9aad-af9b45942ee9
Device Description
CANISTER TUBING LMT-RCTV 02 LIBERANT
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JCX | APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED | General, Plastic Surgery | 878.4780 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34858 | Surgical suction system collection container, single-use | A sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00763000981327 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243418 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 48.0 | Inch | |
| Weight | 162.0 | Kilogram | |
| Width | 40.0 | Inch | |
| Height | 6.0 | Feet |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 140 Degrees Fahrenheit