FDA UDI
In Commercial Distribution
🇺🇸 United States
ROEKO Surgitip
DI: E1654620490
·
Model: 462049
·
Coltène/Whaledent GmbH + Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ROEKO Surgitip
- Primary DI
- E1654620490
- Version / Model
- 462049
- Catalog Number
- 462049
- Company Name
- Coltène/Whaledent GmbH + Co. KG
- Labeler DUNS
- 315494443
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-23
- Public Version
- 3
- Public Version Date
- 2022-03-29
- Public Version Status
- Update
- Public Device Record Key
- 04f23f0b-d43a-431d-9285-03225eef8cad
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| JOL | Catheter And Tip, Suction | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37434 | Dental suction system cannula, single-use | A semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is typically made of disposable plastic materials. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | E1654620490 | HIBCC |
Customer Contacts
- Phone
- +4973458050
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Tip-opening 4.9 mm | ||
| Outer Diameter | 6.5 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 37 – 77 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep away from sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep dry