FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Rocket
DI: 05055270970404
·
Model: R53902
·
ROCKET MEDICAL PLC
Product Codes
0
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Rocket
- Primary DI
- 05055270970404
- Version / Model
- R53902
- Catalog Number
- R53902
- Company Name
- ROCKET MEDICAL PLC
- Labeler DUNS
- 544313588
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-03
- Public Version
- 3
- Public Version Date
- 2023-12-08
- Public Version Status
- Update
- Public Device Record Key
- d7964b5a-fa9a-4d68-ab3a-b619e69f9dd9
- Distribution End Date
- 2023-12-07
Device Description
Rocket DIsposable Bellows Set
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
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35351 | Rectal speculum | A hand-held manual surgical instrument intended to be used to expand or stretch the rectal orifice/canal after it is inserted and opened. It is comprised of two arms joined at a pivot point and is available in various sizes, shapes, and contours; it is usually made of stainless steel. The instrument is used for examination or for the insertion of other instrumentation. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05055270970411 | GS1 | Carton | 10 | Not in Commercial Distribution | 2023-12-07 |
| Primary | 05055270970404 | GS1 | ||||
| Package | 05055270970428 | GS1 | Carton | 2 | Not in Commercial Distribution | 2023-12-07 |
Customer Contacts
- Phone
- +4401914196988
- [email protected]
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 1 – 70 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 101 – 101 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 1 – 70 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -5 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -5 – 30 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 101 – 101 KiloPascal