FDA UDI
In Commercial Distribution
🇺🇸 United States
ExoToe
DI: B605SZR001
·
Model: SZR001
·
EXOTOE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ExoToe
- Primary DI
- B605SZR001
- Version / Model
- SZR001
- Catalog Number
- SZR001
- Company Name
- EXOTOE, LLC
- Labeler DUNS
- 081016089
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-27
- Public Version
- 2
- Public Version Date
- 2023-05-17
- Public Version Status
- Update
- Public Device Record Key
- 7a9cce56-6e1c-4ebb-86cb-820f22b1cead
Device Description
ExoToe Sizing Template 5.5mm, 6.5mm, 7.5mm
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
- 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
- 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 |
|---|---|---|---|---|
| JDR | Staple, Fixation, Bone | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46479 | Surgical implant template, reusable | A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B605SZR001 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172205 | 000 |