FDA UDI
In Commercial Distribution
🇺🇸 United States
AlloSource ProChondrix Sizer Set
DI: 00818614021836
·
Model: 58161-01
·
Maruho Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AlloSource ProChondrix Sizer Set
- Primary DI
- 00818614021836
- Version / Model
- 58161-01
- Company Name
- Maruho Medical, Inc.
- Labeler DUNS
- 117630237
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-17
- Public Version
- 1
- Public Version Date
- 2021-05-25
- Public Version Status
- New
- Public Device Record Key
- 169dd07d-4afa-42c7-ae42-804b52ce7b5f
Device Description
Disposable sizer set: (1) 9-11mm sizer, (1) 13-15mm sizer, (1) 17-20mm sizer
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 |
|---|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63000 | Ligament graft sizer, invasive | A sterile, invasive, surgical device intended to be used to measure the approximate length of graft (autograft or allograft) required to be harvested during an anterior cruciate ligament (ACL) repair. It is typically in the form of a synthetic cord with adjustable beads designed to mark the appropriate length in situ; it is not intended for implantation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00818614021836 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 9 | Millimeter | |
| Outer Diameter | 11 | Millimeter | |
| Outer Diameter | 13 | Millimeter | |
| Outer Diameter | 15 | Millimeter | |
| Outer Diameter | 17 | Millimeter | |
| Outer Diameter | 20 | Millimeter |