AccuFilm® S053
GUDID 20810000526141
AccuFilm® II Booklet Red/Black (5 Booklets of 50)
PARKELL, INC.
Dental articulation paper| Primary Device ID | 20810000526141 |
| NIH Device Record Key | 6d02e6f2-d4b4-442d-9665-ed848075543c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AccuFilm® |
| Version Model Number | Red/Black Booklet |
| Catalog Number | S053 |
| Company DUNS | 009900424 |
| Company Name | PARKELL, INC. |
| Device Count | 50 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810000526147 [Unit of Use] |
| GS1 | 10810000526144 [Primary] |
| GS1 | 20810000526141 [Package] Contains: 10810000526144 Package: Box [5 Units] In Commercial Distribution |
FDA Product Code
| EFH | Paper, Articulation |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2023-12-21 |
| Device Publish Date | 2018-10-19 |
On-Brand Devices [AccuFilm®]
| M595S0532 | AccuFilm® II Booklet Red/Black (5 Booklets of 50) |
| M595S0501 | AccuFilm® Arch Marking Paper- Red/Blue |
| 00810000526116 | AccuFilm® IV Brush-On Marking Liquid |
| 10810000528148 | Accu-Film® Fast-Check Double-Sided Blue/Blue |
| 00810000526123 | Red/Red AccuFilm® II Double-Sided for Korea |
| 00810000526109 | Black/Black AccuFilm® II Double-Sided for Korea |
| 00810000526093 | Red/Black AccuFilm® II Double-Sided for Korea |
| 00810000526086 | Red AccuFilm® I Single-Sided for Korea |
| 00810000526680 | AccuFilm® IV Brush-On Marking Liquid for Korea |
| 20810000526134 | AccuFilm® Arch Marking Paper- Red/Blue |
| 20810000526141 | AccuFilm® II Booklet Red/Black (5 Booklets of 50) |
| 10810000526120 | Red/Red AccuFilm® II Double-Sided |
| 10810000526106 | Black/Black AccuFilm® II Double-Sided |
| 10810000526090 | Red/Black AccuFilm® II Double-Sided |
| M595S0151 | Red AccuFilm® I Single-Sided |
| M595S0141 | Black AccuFilm® I Single-Sided |
Trademark Results [AccuFilm]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACCUFILM 73096917 1076262 Live/Registered |
PARKELL PRODUCTS INC. 1976-08-17 |
 ACCUFILM 72390866 0952694 Dead/Expired |
BISHOP GRAPHICS, INC. 1971-05-03 |
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