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 ID: 00673693181914
• NIH Device Record Key: 6c022f8d-e9d4-429d-9a0f-da93e688f6f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epredia
• Version Model Number: Mark-It™ Tissue Marking Red
• Catalog Number: 5000R
• Company DUNS: 929504710
• Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY
• Device Count: 1
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00673693181914 [Primary]

FDA Product Code

• LEE: Stains, Dye Solution

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-14
• Device Publish Date: 2024-08-06

On-Brand Devices [Epredia]

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