FDA UDI
In Commercial Distribution
🇺🇸 United States
Real Intelligence
DI: 00885556919804
·
Model: ROB30009
·
Smith & Nephew, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Real Intelligence
- Primary DI
- 00885556919804
- Version / Model
- ROB30009
- Catalog Number
- ROB30009
- Company Name
- Smith & Nephew, Inc.
- Labeler DUNS
- 045483575
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-20
- Public Version
- 1
- Public Version Date
- 2026-04-28
- Public Version Status
- New
- Public Device Record Key
- 9d76261b-fdb2-4809-b1ae-d3968d3a69b9
Device Description
Real Intelligence Robotic Drill XT
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| OLO | Orthopedic stereotaxic instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38273 | Thyroxine binding globulin (TBG) IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of thyroxine binding globulin (TBG) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00885556919804 | GS1 |
Customer Contacts
- Phone
- +1(800)238-7538
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K252841 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- 10-90%
- Type
- Special Storage Condition, Specify
- Special Conditions
- 50-106kPa
- Type
- Special Storage Condition, Specify
- Special Conditions
- -10-55C
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry