FDA UDI
In Commercial Distribution
🇺🇸 United States
Walcott Rx Products
DI: 00840285311732
·
Model: Rx4-335L
·
Walcott Rx Product Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Walcott Rx Products
- Primary DI
- 00840285311732
- Version / Model
- Rx4-335L
- Company Name
- Walcott Rx Product Inc
- Labeler DUNS
- 837689694
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-10
- Public Version
- 1
- Public Version Date
- 2022-08-18
- Public Version Status
- New
- Public Device Record Key
- 38fb6a0c-71a4-4c24-b6bd-ba046744aa45
Device Description
Curette
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| HNZ | Curette, ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32736 | Ophthalmic chair, manual | A manually-operated device designed to position a patient in a seated or reclined posture for easy access and patient comfort during an ophthalmic examination, treatment, or surgical intervention. It will typically have hand-operated adjustments and may be freestanding or connected to another device or system. It is not designed to position the patient completely horizontally during surgery (i.e., it is not an operating table). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840285311732 | GS1 |
Customer Contacts
- Phone
- +1(800)837-9875
- [email protected]