FDA UDI
In Commercial Distribution
🇺🇸 United States
Curved Standard Ball Burr XL 5.0 mm
DI: 00859273007250
·
Model: R-10025
·
RELIGN CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Curved Standard Ball Burr XL 5.0 mm
- Primary DI
- 00859273007250
- Version / Model
- R-10025
- Catalog Number
- R-10025
- Company Name
- RELIGN CORPORATION
- Labeler DUNS
- 080031617
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-16
- Public Version
- 1
- Public Version Date
- 2022-06-24
- Public Version Status
- New
- Public Device Record Key
- fea19ed7-04e4-49e8-8278-9a282a2af1e8
Device Description
Standard burr, disposable
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| HRX | Arthroscope | Orthopedic | 888.1100 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45553 | Orthopaedic bur, single-use | A sterile, rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10859273007257 | GS1 | Shelf Box | 4 | In Commercial Distribution | |
| Primary | 00859273007250 | GS1 |
Customer Contacts
- Phone
- (800) 253-6190
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162770 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 5.0 | Millimeter |