FDA UDI
In Commercial Distribution
🇺🇸 United States
Articulating Paper
DI: D701ARPH2
·
Model: ARP-H
·
PULPDENT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
72
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Basic Information
- Brand Name
- Articulating Paper
- Primary DI
- D701ARPH2
- Version / Model
- ARP-H
- Company Name
- PULPDENT CORPORATION
- Labeler DUNS
- 001006089
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 72
- Record Status
- Published
- Publish Date
- 2021-09-21
- Public Version
- 1
- Public Version Date
- 2021-09-29
- Public Version Status
- New
- Public Device Record Key
- dcf655c7-12c2-4e4f-9dfd-fd670491e0ba
Device Description
Double check, 50 microns. Horseshoe, Red & Blue, 72 sheets
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| EFK | Forceps, Articulation Paper | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16181 | Dental articulation paper | A strip or sheet of suitable material coated with pigment and used for marking areas of contact between opposite teeth, restorations or appliances. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D701ARPH2 | HIBCC | ||||
| Unit of Use | D701ARPH1 | HIBCC |