FDA UDI
In Commercial Distribution
🇺🇸 United States
KLOCKNER
DI: 08435451660350
·
Model: 9635-KL
·
SOADCO, S.L.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- KLOCKNER
- Primary DI
- 08435451660350
- Version / Model
- 9635-KL
- Catalog Number
- 9635-KL
- Company Name
- SOADCO, S.L.
- Labeler DUNS
- 464517122
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-14
- Public Version
- 1
- Public Version Date
- 2025-02-24
- Public Version Status
- New
- Public Device Record Key
- 85ec5a31-bf63-4473-b00c-3075c4c0af8b
Device Description
SK2 HEXAGONAL BALL ATTACHMENT [M-AT2-AP2.6]
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
- 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 |
|---|---|---|---|---|
| NHA | Abutment, implant, dental, endosseous | Dental | 872.3630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38590 | Overdenture | A custom-made, removable, artificial replacement for some or all teeth in the lower or upper jaw (mandible or maxilla) that is retained in the mouth with precision dental attachments. The attachments can be placed in retained tooth roots or dental implants. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08435451660350 | GS1 |
Customer Contacts
- Phone
- +376800593
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K010132 | 000 |