FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Rocket
DI: 05055270909329
·
Model: R28410
·
ROCKET MEDICAL PLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Rocket
- Primary DI
- 05055270909329
- Version / Model
- R28410
- Catalog Number
- R28410
- Company Name
- ROCKET MEDICAL PLC
- Labeler DUNS
- 544313588
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-30
- Public Version
- 2
- Public Version Date
- 2023-12-08
- Public Version Status
- Update
- Public Device Record Key
- 9f4ad25e-6985-4e4e-8495-040ad4b1c38d
- Distribution End Date
- 2023-12-07
Device Description
Rocket Tubing Mount Angled
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| MQG | Accessory, Assisted Reproduction | Obstetrics/Gynecology | 884.6120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37798 | Suction system filter, microbial | A screening device intended to be installed within a suction system and which has a membrane pore size small enough to retain bacterial pathogens, thus preventing the environment from becoming infected and decreasing the risk of cross-infection to subsequent patients. It is typically directly connected to the suction system collection bottle/canister, or as a common filter serving more than one bottle/canister through a switching mechanism, or in a tubing line between the suction bottle/canister and the suction pump, or at the suction pump exhaust where driving gases are discarded. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055270909329 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K000394 | 000 |