FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MEDICOM PRO-MATRIX
DI: 10686864049835
·
Model: 30020 PK8
·
AMD Medicom Inc
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- MEDICOM PRO-MATRIX
- Primary DI
- 10686864049835
- Version / Model
- 30020 PK8
- Catalog Number
- 30020 PK8
- Company Name
- AMD Medicom Inc
- Labeler DUNS
- 256880576
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2019-01-18
- Public Version
- 2
- Public Version Date
- 2024-02-07
- Public Version Status
- Update
- Public Device Record Key
- f5feb25c-feb0-4477-848a-170830e79afc
- Distribution End Date
- 2024-02-06
Device Description
MEDICOM PRO-MATRIX BAND 4,5 mm Narrow
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DZN | INSTRUMENTS, DENTAL HAND | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38786 | Dental matrix band, single-use | A band or strip of strong material (typically a transparent plastic) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is typically held snugly around the tooth by a matrix retainer. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20686864049832 | GS1 | Outer Case | 8 | Not in Commercial Distribution | 2024-02-06 |
| Primary | 10686864049835 | GS1 | ||||
| Unit of Use | 00686864049838 | GS1 |
Customer Contacts
- Phone
- +1(514)636-6262 ext. 2309
- [email protected]
- Phone
- +1(514)636-6262
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 4 1/2 Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Cool dry place