FDA UDI
In Commercial Distribution
🇺🇸 United States
J&J Instruments
DI: 00817524028812
·
Model: 55-0009
·
J & J INSTRUMENTS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- J&J Instruments
- Primary DI
- 00817524028812
- Version / Model
- 55-0009
- Catalog Number
- 55-0009
- Company Name
- J & J INSTRUMENTS INC
- Labeler DUNS
- 783328149
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-01
- Public Version
- 2
- Public Version Date
- 2023-06-08
- Public Version Status
- Update
- Public Device Record Key
- 92d87968-fc97-4200-acf6-d4c658a7472f
Device Description
BRACKET PLACER 4.25" POSTERIOR
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| ECQ | Aligner, Bracket, Orthodontic | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62086 | Self-ligating orthodontic bracket open/close tool | A hand-held dental instrument intended to be used by an orthodontist for opening/closing a self-ligating orthodontic bracket and/or tube. It is made of metal and is in the form of a handle with thin pronged ends designed to release/close the orthodontic appliance clip mechanism; it may also be used to hold the archwire in place to assist manual closing of the clip. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817524028812 | GS1 |