FDA UDI
In Commercial Distribution
🇺🇸 United States
KOHDENT
DI: 04251436919787
·
Model: 6549
·
Kohdent Roland Kohler Medizintechnik GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- KOHDENT
- Primary DI
- 04251436919787
- Version / Model
- 6549
- Catalog Number
- 6549
- Company Name
- Kohdent Roland Kohler Medizintechnik GmbH & Co. KG
- Labeler DUNS
- 324006097
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-30
- Public Version
- 1
- Public Version Date
- 2021-09-07
- Public Version Status
- New
- Public Device Record Key
- 08ee7226-6278-4e6c-a291-ceedb0c39f98
Device Description
Application syringe 1,2mm diameter curved
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EIC | SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18069 | Needleless medication/vaccine injector, mechanical | A hand-held, mechanically-powered (e.g., spring-powered) device designed to inject medication (especially a local anaesthetic, vaccine or medication) transcutaneously into the human body. It is a manually-operated, needleless device that can have various configurations according to application. It will typically be a pistol-shaped plunger driven instrument with single or multi-pointed holed barrels through which the medication/vaccine is driven under high pressure. The delivered medication/vaccine will typically be supplied in prefilled containers. This device is not a hypodermic syringe. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04251436919787 | GS1 |
Customer Contacts
- Phone
- +497771649990
- [email protected]