FDA UDI
In Commercial Distribution
🇺🇸 United States
Reciproc Minima
DI: J003TSTRMPPM00AST2
·
Model: TSTRMPPM00AST
·
MAILLEFER INSTRUMENTS HOLDING Sàrl
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
180
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Basic Information
- Brand Name
- Reciproc Minima
- Primary DI
- J003TSTRMPPM00AST2
- Version / Model
- TSTRMPPM00AST
- Catalog Number
- TSTRMPPM00AST
- Company Name
- MAILLEFER INSTRUMENTS HOLDING Sàrl
- Labeler DUNS
- 480538495
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 180
- Record Status
- Published
- Publish Date
- 2025-08-05
- Public Version
- 2
- Public Version Date
- 2025-09-18
- Public Version Status
- Update
- Public Device Record Key
- 52474e74-e35c-455e-a08d-b289a73bbd7b
Device Description
Reciproc Minima Paper Points Assortment (30x20, 90x25, 30x 35, 30x45)
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EKN | POINT, PAPER, ENDODONTIC | Dental | 872.3830 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38777 | Endodontic paper point | A non-medicated absorbent point used in endodontic procedures that has been sterilized once in a manner approved by the manufacturer. 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 | J003TSTRMPPM00AST1 | HIBCC | ||||
| Primary | J003TSTRMPPM00AST2 | HIBCC |