FDA UDI
In Commercial Distribution
🇺🇸 United States
LEOS
DI: 00196449000340
·
Model: 7622-0451
·
Tyber Medical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- LEOS
- Primary DI
- 00196449000340
- Version / Model
- 7622-0451
- Catalog Number
- 7622-0451
- Company Name
- Tyber Medical, LLC
- Labeler DUNS
- 010968002
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-04
- Public Version
- 7
- Public Version Date
- 2025-11-20
- Public Version Status
- Update
- Public Device Record Key
- 9728bec1-efb1-40cb-8cd2-c9f7804f0827
Device Description
LEOS Y-Shape Plate, 5 Hole, Beta
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
- MR Conditional
- Direct Marking Exempt
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HRS | Plate, fixation, bone | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46647 | Orthopaedic fixation plate, non-bioabsorbable | A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00196449000340 | GS1 |
Customer Contacts
- Phone
- +1(866)761-0933
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222465 | 000 |