FDA UDI
In Commercial Distribution
🇺🇸 United States
STERLING, REACT, GATOR
DI: 10845854029411
·
Model: 35GTR-RA-ZZ
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
6
Basic Information
- Brand Name
- STERLING, REACT, GATOR
- Primary DI
- 10845854029411
- Version / Model
- 35GTR-RA-ZZ
- Catalog Number
- 35GTR-RA-ZZ
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2020-09-24
- Public Version
- 4
- Public Version Date
- 2023-05-04
- Public Version Status
- Update
- Public Device Record Key
- 15196a74-3cd0-4ada-93b2-a9298d2e5f41
Device Description
3.5MM STERLING REACT GATOR
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GFA | BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL | General, Plastic Surgery | 878.4820 | 1 |
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 | 20845854029418 | GS1 | CARTON | 6 | In Commercial Distribution | |
| Primary | 10845854029411 | GS1 | ||||
| Unit of Use | 00845854029414 | GS1 |
Customer Contacts
- Phone
- +1(866)426-6633
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 3.5 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- KEEP DRY