FDA UDI
In Commercial Distribution
🇺🇸 United States
Retrax System R-101 Packing Instrument
DI: 00310866002170
·
Model: 26101
·
PASCAL COMPANY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Retrax System R-101 Packing Instrument
- Primary DI
- 00310866002170
- Version / Model
- 26101
- Catalog Number
- 26101
- Company Name
- PASCAL COMPANY, INC.
- Labeler DUNS
- 009260217
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-09
- Public Version
- 1
- Public Version Date
- 2022-05-17
- Public Version Status
- New
- Public Device Record Key
- 6f171fb6-80f0-4bfe-9498-e29856ce0f26
Device Description
Retrax System retraction cord packing instruments are stainless steel. They have a larger, round handle and the handle is stainless steel with a black electroplated finish. The tips are polished stainless steel.
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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- 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
- Dry Heat Sterilization, Moist Heat or Steam Sterilization, High-level Disinfectant
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EIF | Accessories, Retractor, Dental | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13380 | Hand-held dental retractor | A hand-held, non-self-retaining dental instrument intended to be used to manually displace soft tissues of the oral cavity to improve their visualization and access, and to afford them protection during oral surgical procedures. It is typically a metallic device and includes a shaped/hooked blade with a handle/holding portion. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00310866002170 | GS1 |
Customer Contacts
- Phone
- 8004268051
- [email protected]