FDA UDI
In Commercial Distribution
🇺🇸 United States
Ackermann
DI: 00842092107485
·
Model: 0102124
·
Preat Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Ackermann
- Primary DI
- 00842092107485
- Version / Model
- 0102124
- Catalog Number
- 0102124
- Company Name
- Preat Corporation
- Labeler DUNS
- 117776048
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-24
- Public Version
- 4
- Public Version Date
- 2024-01-11
- Public Version Status
- Update
- Public Device Record Key
- 40594be4-37c3-4412-93a4-a237d073b450
Device Description
Ackermann BL Clip GOLD
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| EGG | ATTACHMENT, PRECISION, ALL | Dental | 872.3165 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63963 | Dental appliance/prosthesis connector | A small device in the form of a combination sleeve/screw intended to provide a secure connection between two dental suprastructures, or between a dental suprastructure and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture); it may also be used to provide an anchor point for a tool to temporarily remove a prosthesis/restoration, e.g., for cleaning. It is in the form of a sleeve and screw set where the sleeve is fixed in a pre-drilled hole or glued to the outside of the appliance. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00842092155646 | GS1 | Pack | 6 | In Commercial Distribution | |
| Primary | 00842092107485 | GS1 |
Customer Contacts
- Phone
- +1(800) 232-7732
- [email protected]