FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Integra® Miltex®
DI: 10381780472407
·
Model: 700-505
·
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
60
Basic Information
- Brand Name
- Integra® Miltex®
- Primary DI
- 10381780472407
- Version / Model
- 700-505
- Catalog Number
- 700-505
- Company Name
- INTEGRA LIFESCIENCES PRODUCTION CORPORATION
- Labeler DUNS
- 081277700
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 60
- Record Status
- Published
- Publish Date
- 2018-08-16
- Public Version
- 3
- Public Version Date
- 2022-07-19
- Public Version Status
- Update
- Public Device Record Key
- d2ec0a0c-dc9f-4bf7-ac37-59d10963f4f7
- Distribution End Date
- 2022-05-01
Device Description
Precise™ Gutta Percha, .04 Taper, Size #35, 60/PK
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EKM | GUTTA-PERCHA | Dental | 872.3850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45081 | Synthetic gutta-percha | A dental material made from a polymer-based, synthetic gutta-percha containing fillers and radiopacifiers in a soft resin matrix, intended to fill the root canal of a tooth. This material has the ability to resist leakage significantly better than natural gutta-percha based obturation whilst strengthening the root resulting in roots having a coronal and apical seal as part of the canal filling process. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | H8347005051 | HIBCC | ||||
| Primary | 10381780472407 | GS1 | ||||
| Unit of Use | 00381780472400 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away From Sunlight