FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Integra® Miltex®
DI: 10381780501596
·
Model: 700511-7000-001
·
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2500
Basic Information
- Brand Name
- Integra® Miltex®
- Primary DI
- 10381780501596
- Version / Model
- 700511-7000-001
- Catalog Number
- 700511-7000-001
- Company Name
- INTEGRA LIFESCIENCES PRODUCTION CORPORATION
- Labeler DUNS
- 081277700
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 2500
- Record Status
- Published
- Publish Date
- 2018-09-18
- Public Version
- 3
- Public Version Date
- 2022-07-19
- Public Version Status
- Update
- Public Device Record Key
- e9446996-643f-4f76-a757-137e10e60a05
- Distribution End Date
- 2022-05-01
Device Description
Endo Stop Dispenser - Silicone, Rust, Package of 2,500
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
- 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 |
|---|---|---|---|---|
| EKS | FILE, PULP CANAL, ENDODONTIC | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45123 | Endodontic stopper | A device that is used as a measuring reference point on an endodontic instrument used in a root canal procedure. It is typically designed as a flat ring made of an elastic material (e.g., silicone) that is placed at a predetermined distance from the distal end of the instrument (e.g., an endodontic file) allowing the operator to gauge the maximum depth of penetration. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | H83470051170000011 | HIBCC | ||||
| Primary | 10381780501596 | GS1 | ||||
| Unit of Use | 00381780501599 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]