Epredia 5000R

GUDID 00673693181914

Tissue Marking Dyes are intended as an aid in the orientation, of excised surgical specimens through frozen sectioning, processing, and sectioning, and subsequent microscopic examination of tissues. The marking of multiple margins with these dyes is especially useful for identification in skin biopsies, a technique known as Moh’s surgery. These dyes are normally applied to fresh tissue but may also be used with fixed tissue. Whether fresh or fixed, the tissue should be blotted to remove excess fluid from the surface before applying the dye. Tissue Marking Dyes will permanently bond to the tissue 1 to 2 minutes after application. The tissue can then be frozen and prepared for sectioning or placed in formalin or other fixatives and processed for paraffin embedding.

RICHARD-ALLAN SCIENTIFIC COMPANY

Biopsy tissue marking dye kit IVD
Primary Device ID00673693181914
NIH Device Record Key6c022f8d-e9d4-429d-9a0f-da93e688f6f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameEpredia
Version Model NumberMark-It™ Tissue Marking Red
Catalog Number5000R
Company DUNS929504710
Company NameRICHARD-ALLAN SCIENTIFIC COMPANY
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100673693181914 [Primary]

FDA Product Code

LEEStains, Dye Solution

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-14
Device Publish Date2024-08-06

On-Brand Devices [Epredia]

00673693718967RM-2104-R7-A
00673693718868MS-314-S1-A
00673693718851MS-314-S0-A
00673693718844MS-314-S-A
00673693718837MS-314-RQ-A
00673693718813MS-1919-RQ-A
00673693718806MS-1919-R7-A
00673693718790MS-1919-A0-A
00673693718783MS-1919-A1-A
00673693718776MS-1919-A-A
00673693658386MS-730-P-A
00673693658331MS-298-RQ-A
00673693658287MS-298-P-A
00673693658249MS-1826-S1-A
00673693658225MS-1826-S-A
00673693658201MS-1826-R7-A
00673693658188MS-1458-S1-A
00673693658164MS-1458-S-A
00067369371882MS-314-R7-A
00673693719049RM-9130-RQ-A
00673693719032RM-9130-R7-A
00673693719025RM-9130-A1-A
00673693719018RM-9130-A0-A
00673693719001RM-9130-A-A
00673693718998RM-2104-S0-A
00673693718981RM-2104-S-A
00673693718974RM-2104-RQ-A
00673693659017RM-9103-S1-A
00673693658997RM-9103-S-A
00673693658980RM-9103-RQ-A
00673693658973RM-9103-R7-A
00673693658898RM-2112-S-A
00673693658812RB-9070-RQ-A
00673693658805RB-9070-R7-A
00673693658782RB-9070-P1-A
00673693658768RB-9070-P-A
00673693658751RB-9031-RQ-A
00673693658720RB-9031-P1-A
00673693658409MS-730-P1-A
00673693658959Progesterone Recept. [YR85] ASR
00673693658942Progesterone Recept. [YR85] ASR
00673693658522ER (Cocktail) [1D5+6F11] ASR
00673693658515ER (Cocktail) [1D5+6F11] ASR.
00673693658508ER (Cocktail) [1D5+6F11] ASR
00673693658492ER (Cocktail) [1D5+6F11] ASR
00673693658454Estrogen Receptor [1D5] ASR.
00673693079877Neutral Buffered Formalin (NBF) is a general primary fixative for tissue specimens. A fixative i
00673693763233Neutral Buffered Formalin (NBF) is a general primary fixative for tissue specimens. A fixative i
00673693755122Neutral Buffered Formalin (NBF) is a general primary fixative for tissue specimens. A fixative i
00673693711609Neutral Buffered Formalin (NBF) is a general primary fixative for tissue specimens. A fixative i

Trademark Results [Epredia]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EPREDIA
EPREDIA
97821165 not registered Live/Pending
New Erie Scientific LLC
2023-03-03
EPREDIA
EPREDIA
88473846 not registered Live/Pending
New Erie Scientific LLC
2019-06-14

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