FDA UDI
In Commercial Distribution
🇺🇸 United States
STANDARD SHAVER™ 4.2MM
DI: 00889024681101
·
Model: R10029
·
RELIGN CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- STANDARD SHAVER™ 4.2MM
- Primary DI
- 00889024681101
- Version / Model
- R10029
- Catalog Number
- R10029
- Company Name
- RELIGN CORPORATION
- Labeler DUNS
- 080031617
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-07
- Public Version
- 1
- Public Version Date
- 2025-10-15
- Public Version Status
- New
- Public Device Record Key
- e07d2a70-dd7e-4342-8b99-fccabde8b3a6
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 |
|---|---|---|---|---|
| 41499 | Arthroscopic shaver system blade, single-use | A cutting device designed for use in a powered arthroscopic shaver system handpiece (not included) for bone and soft-tissue resection during arthroscopic surgery on a joint (e.g., a knee, shoulder, or ankle). It is locked into the handpiece, and typically consists of a small outer tube with a hub and a rotating inner tube with a connector that performs a rotational or reciprocating (back and forth) motion. It is typically made of high-grade stainless steel. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00889024681125 | GS1 | EA | 4 | In Commercial Distribution | |
| Primary | 00889024681101 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241008 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 4.2 | Millimeter |