FDA UDI
In Commercial Distribution
🇺🇸 United States
TRUFIX Bone Fixation System
DI: 00614950007066
·
Model: 9600313
·
ACE SURGICAL SUPPLY CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- TRUFIX Bone Fixation System
- Primary DI
- 00614950007066
- Version / Model
- 9600313
- Catalog Number
- 9600313
- Company Name
- ACE SURGICAL SUPPLY CO., INC.
- Labeler DUNS
- 042763706
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-12-28
- Public Version
- 5
- Public Version Date
- 2019-10-23
- Public Version Status
- Update
- Public Device Record Key
- 0c9ace62-ccbf-4972-8078-143cd4d632c7
Device Description
truTACK 2.5HD 3TL 10/PK THREADED HX TI STERILE (6AL4VELI)
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
- Yes
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| OAT | Implant, endosseous, orthodontic | Dental | 872.3640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46552 | Dental implantation drilling template retention pin | A small, metal peg designed to provide initial stability to anchor a custom-made surgical template that is fitted over the ridge of existing teeth and/or gum of a patient during the first stage of a dental implantation procedure. It is inserted through lateral guide hole(s) in the template, and is pressed into pre-drilled hole(s) in the jawbone. It is used for implantation procedures where a tooth/teeth are missing and a template is used to provide the dentist with the correct drilling position(s) for the implant(s). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10614950007063 | GS1 | Tyvec Bag | 10 | In Commercial Distribution | |
| Primary | 00614950007066 | GS1 |
Customer Contacts
- Phone
- +1(508)588-3100 ext. 214
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K951392 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 3 | Millimeter |