FDA UDI
In Commercial Distribution
🇺🇸 United States
Response Derotation Instruments
DI: 00840194428811
·
Model: 01-1300-0257
·
ORTHOPEDIATRICS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Response Derotation Instruments
- Primary DI
- 00840194428811
- Version / Model
- 01-1300-0257
- Catalog Number
- 01-1300-0257
- Company Name
- ORTHOPEDIATRICS CORP.
- Labeler DUNS
- 796416191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-25
- Public Version
- 2
- Public Version Date
- 2025-11-20
- Public Version Status
- Update
- Public Device Record Key
- c0804f47-1fec-4e36-adab-4fe38e2a4d12
Device Description
Derotation Cross Bar - 225mm
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
- Yes
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 |
|---|---|---|---|---|
| 44795 | Manual orthopaedic bender, reusable | A manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. It is typically in the form of pliers, a rod-like (e.g., pin) or bench-top device. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840194428811 | GS1 |