FDA UDI
In Commercial Distribution
🇺🇸 United States
OMEGA
DI: 07613327514148
·
Model: 3910500653
·
STRYKER CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- OMEGA
- Primary DI
- 07613327514148
- Version / Model
- 3910500653
- Catalog Number
- 3910-500-653
- Company Name
- STRYKER CORPORATION
- Labeler DUNS
- 187502109
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-30
- Public Version
- 1
- Public Version Date
- 2020-10-08
- Public Version Status
- New
- Public Device Record Key
- d8eea214-9403-4a5c-b1b8-2b8c70217f8e
Device Description
Omega 6.5mm PEEK Knotless Anchor System, Single
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
- MR Safe
- Direct Marking Exempt
- No
- 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 |
|---|---|---|---|---|
| MBI | Fastener, fixation, nondegradable, soft tissue | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45062 | Tendon/ligament bone anchor, non-bioabsorbable | A non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)]. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 37613327514149 | GS1 | pack | 5 | In Commercial Distribution | |
| Primary | 07613327514148 | GS1 |
Customer Contacts
- Phone
- +1(866)624-4422
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181083 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Diameter: 6.5 Millimeter |