Primary Device ID | 00810000526086 |
NIH Device Record Key | 4acdc58c-1a7e-4a8d-9789-b3b79e8bb014 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AccuFilm® |
Version Model Number | S015-K |
Catalog Number | S015-K |
Company DUNS | 009900424 |
Company Name | PARKELL, INC. |
Device Count | 280 |
DM Exempt | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810000526086 [Unit of Use] |
GS1 | 10810000526168 [Primary] |
EFH | Paper, Articulation |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-10-11 |
Device Publish Date | 2021-10-01 |
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 |
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 |