FDA UDI
In Commercial Distribution
🇺🇸 United States
20mm x 20mm x 20mm Staple
DI: 00812926028279
·
Model: 500-20-101
·
Trilliant Surgical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 20mm x 20mm x 20mm Staple
- Primary DI
- 00812926028279
- Version / Model
- 500-20-101
- Company Name
- Trilliant Surgical, LLC
- Labeler DUNS
- 828829072
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-05
- Public Version
- 4
- Public Version Date
- 2022-04-06
- Public Version Status
- Update
- Public Device Record Key
- 4952a82b-f9e2-4fa5-ba9a-84dd6e07b343
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| JDR | Staple, Fixation, Bone | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61668 | Orthopaedic bone staple, non-adjustable, non-sterile | A non-sterile, non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Disposable devices associated with implantation may be included. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812926028279 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172405 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 20 | Millimeter | |
| Height | 20 | Millimeter |