FDA UDI
In Commercial Distribution
🇺🇸 United States
Patterson Dental - Steri-Endo Guard, Endo Assist - Replacement Foam for Steri-En
DI: 00840161311665
·
Model: 50Z451-PAT
·
ZIRC DENTAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
48
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Basic Information
- Brand Name
- Patterson Dental - Steri-Endo Guard, Endo Assist - Replacement Foam for Steri-En
- Primary DI
- 00840161311665
- Version / Model
- 50Z451-PAT
- Company Name
- ZIRC DENTAL PRODUCTS, INC.
- Labeler DUNS
- 064783913
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 48
- Record Status
- Published
- Publish Date
- 2026-02-19
- Public Version
- 1
- Public Version Date
- 2026-02-27
- Public Version Status
- New
- Public Device Record Key
- 86344b8d-39f1-44b1-b495-4de19993822f
Device Description
Foam refills for Endo Guards and Endo Assist
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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64815 | Endodontic instrument-holding insert, single-use | A device intended to be fitted into an endodontic instrument holder housing and used chairside during a dental endodontic procedure to hold and temporarily store sharp endodontic instruments (e.g., files/rasps). It is in the form of a spongy foam insert into which the sharp end of instruments is inserted, thereby reducing risk of injury. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00840161302144 | GS1 | ||||
| Primary | 00840161311665 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 45 | Millimeter | |
| Width | 23 | Millimeter | |
| Height | 15 | Millimeter |