FDA UDI
In Commercial Distribution
🇺🇸 United States
Broken Screw Removal Instruments
DI: 00840194478458
·
Model: 01-9200-1035
·
ORTHOPEDIATRICS CORP.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Broken Screw Removal Instruments
- Primary DI
- 00840194478458
- Version / Model
- 01-9200-1035
- Catalog Number
- 01-9200-1035
- Company Name
- ORTHOPEDIATRICS CORP.
- Labeler DUNS
- 796416191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-07
- Public Version
- 2
- Public Version Date
- 2024-09-11
- Public Version Status
- Update
- Public Device Record Key
- 6cddc7c1-35f7-4d3b-897a-f7b82865c6e9
Device Description
3.5mm Easy Out
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
- 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 |
|---|---|---|---|---|
| GFC | DRIVER, SURGICAL, PIN | General, Plastic Surgery | 878.4820 | 1 |
| HXX | SCREWDRIVER | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64237 | Orthopaedic inorganic implant inserter/extractor, single-use | A hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840194478458 | GS1 |