FDA UDI
In Commercial Distribution
🇺🇸 United States
Imprint™ 3 Quick Step Ultra-Regular Body
DI: 04035077005654
·
Model: 36955
·
3M Deutschland GmbH
Product Codes
2
GMDN Terms
2
Identifiers
2
Pkg Device Count
4
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Basic Information
- Brand Name
- Imprint™ 3 Quick Step Ultra-Regular Body
- Primary DI
- 04035077005654
- Version / Model
- 36955
- Catalog Number
- 36955
- Company Name
- 3M Deutschland GmbH
- Labeler DUNS
- 315731711
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2017-08-04
- Public Version
- 3
- Public Version Date
- 2018-12-07
- Public Version Status
- Update
- Public Device Record Key
- f93a7026-ee5f-4844-87a2-e9b0816aa3bf
Device Description
3M™ ESPE™ Imprint™ 3 Quick Step Ultra Regular Body VPS Impression Material Refill, 36955 DM DI = 04035077028011
Device Characteristics
- Single Use
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| ELW | MATERIAL, IMPRESSION | Dental | 872.3660 | 2 |
| EID | SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35866 | Silicone dental impression material | An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device. | No | Active |
| 60855 | Neurofilament light protein IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of neurofilament light protein in a clinical specimen. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04035077005654 | GS1 | ||||
| Unit of Use | 04035077028011 | GS1 |
Customer Contacts
- Phone
- +1(800)634-2249
- [email protected]