FDA UDI
In Commercial Distribution
🇺🇸 United States
Whistler Pedicle Screw System
DI: 00195860030028
·
Model: WI-079
·
Evolution Spine LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Whistler Pedicle Screw System
- Primary DI
- 00195860030028
- Version / Model
- WI-079
- Catalog Number
- WI-079
- Company Name
- Evolution Spine LLC
- Labeler DUNS
- 116940934
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-29
- Public Version
- 1
- Public Version Date
- 2025-09-08
- Public Version Status
- New
- Public Device Record Key
- b075e922-e985-409a-a991-5e50c62c747f
Device Description
Rod Caliper
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
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXH | Orthopedic manual surgical instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32262 | General-purpose calliper, metallic | A manually-operated metallic device with an analogue Vernier scale designed to make accurate measurements of a patient's anatomy, or of other objects, during surgery, autopsy, or in other clinical settings. It is intended to make external measurements (e.g., external diameter, thickness), internal measurements (e.g., internal diameter, depth), measure length, or make step measurements (i.e., from a larger edge to a lesser edge on an object). It is typically made of stainless steel or chrome-plated steel and can be sterilized in a steam sterilizer (an autoclave). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00195860030028 | GS1 |
Customer Contacts
- Phone
- +1(214)281-8871
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182478 | 000 |