FDA UDI
Not in Commercial Distribution
🇺🇸 United States
VARIAX
DI: 07613154754823
·
Model: 45-35005S
·
Stryker GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- VARIAX
- Primary DI
- 07613154754823
- Version / Model
- 45-35005S
- Catalog Number
- 45-35005S
- Company Name
- Stryker GmbH
- Labeler DUNS
- 481999654
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-24
- Public Version
- 4
- Public Version Date
- 2025-04-14
- Public Version Status
- Update
- Public Device Record Key
- e1c4ca1a-06db-4448-862e-4aafa75db469
- Distribution End Date
- 2022-11-01
Device Description
Tap for 3.5mm Screws, AO,WL 70mm
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
- Yes
- 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 |
|---|---|---|---|---|
| HTW | BIT, DRILL | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56708 | Bone tap, single-use | A surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613154754823 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Diameter: 3.5 Millimeter | ||
| Length | 122.0 | Millimeter |