FDA UDI
In Commercial Distribution
🇺🇸 United States
SSA
DI: 00818614022444
·
Model: DS-1210
·
Maruho Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SSA
- Primary DI
- 00818614022444
- Version / Model
- DS-1210
- Company Name
- Maruho Medical, Inc.
- Labeler DUNS
- 117630237
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-02
- Public Version
- 3
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- f51a9122-f89b-4a87-8abe-ef7c169834c5
Device Description
12mm Distraction Screw
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
- Yes
- 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 |
|---|---|---|---|---|
| 62546 | Intraoperative orthopaedic bone pin/screw, single-use | A small rod intended to be inserted into bone to temporarily anchor a surgical instrument (e.g., retractor, implant aligner) and/or implantable device (e.g., fixation plate) to the bone during an orthopaedic surgical procedure; it is not left in situ after the procedure. It may be wholly- or partially-threaded for screwing into bone, and may have other physical features to enable fixation of surgical instruments/devices. It is made of metallic (e.g., stainless steel) or polymer (radiolucent) material and is available in various shapes and sizes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00818614022444 | GS1 | ||||
| Package | 10818614022441 | GS1 | box | 10 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 12 | Millimeter |