Fisherbrand 14959103

GUDID 00613647000618

FB ENDOCERVEX CYTO BRUSH 50/PK

FISHER SCIENTIFIC COMPANY L.L.C.

Cervical cytology brush

• Primary Device ID: 00613647000618
• NIH Device Record Key: 4b21cc22-b5b7-4b90-a62b-3764b7e6dc72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fisherbrand
• Version Model Number: 14959103
• Catalog Number: 14959103
• Company DUNS: 004321519
• Company Name: FISHER SCIENTIFIC COMPANY L.L.C.
• Device Count: 50
• DM Exempt: true
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613647000618 [Primary]
GS1	10613647000615 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001119

FDA Product Code

• HHT: SPATULA, CERVICAL, CYTOLOGICAL

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: 2018-07-06
• Device Publish Date: 2016-09-29

On-Brand Devices [Fisherbrand]

• 20613647001398: Sharps-A-Gator Sharps Containers
• 00613647001387: Fisherbrand Lead-Free Autoclave Tape 1" x 60 Yard 1 roll
• 00613647001370: Fisherbrand Lead-Free Autoclave Tape 1" x 60 Yard 3 rolls
• 00613647001363: Fisherbrand Lead-Free Autoclave Tape 3/4" x 60 Yard 1 roll
• 00613647001356: Fisherbrand Lead-Free Autoclave Tape 3/4" x 60 Yard 4 rolls
• 00613647000823: Glucose Tolerance Beverage 50G PNCH NC PLAS
• 00613647000816: Glucose Tolerance Beverage 75G LEM NC PLAS FB 24/CS
• 00613647000809: Glucose Tolerance Beverage 75G PNCH NC PLAS FB
• 00613647000793: Glucose Tolerance Beverage 75G ORNG NC PLAS FB
• 00613647000786: Glucose Tolerance Beverage 50GM LEM NC PLAS FB
• 00613647000779: Glucose Tolerance Beverage 100G PNCH NC PLAS FB 24/CS
• 00613647000762: Glucose Tolerance Beverage 100G ORNG NC PLAS FB
• 00613647000755: Glucose Tolerance Beverage 50G ORNG NC PLAS FB
• 00613647000748: Glucose Tolerance Beverage LEM NC PLAS FB 24/CS
• 00613647000731: 1X60 YARD AUTOCLAVE TAPE
• 00613647000724: 1/2X60 YARD AUTOCLAVE TAPE
• 00613647000717: 3/4X60 YARD AUTOCLAVE TAPE
• 00613647000625: FB ENDOCERVEX BRUSH-S 50/PK
• 00613647000618: FB ENDOCERVEX CYTO BRUSH 50/PK
• 00613647000601: FB CERVES BRUSH COMBI 50/PK
• 00613647000595: FB CERVEX BRUSH 1-STP 50/PK
• 20613647000506: URINE RGNT STRIP 10SG 100/PK
• 20613647000490: CONTAINER RECTANGLE PLAS 7GAL
• 20613647000483: CONTAINER RIGID RD 7.5GAL
• 20613647000476: FB SHARPS CONTAINER RECT 10GAL
• 20613647000469: 2 GAL FBRAND SHARPS CNTNR EA
• 20613647000452: CONTAINER LOW TOP TRAN 3.5GAL
• 20613647000445: INPATIENT CL/TOP RD BASE 5QT
• 20613647000438: FISHERBRAND CONTAINR PHLEB 1QT
• 20613647000056: 7X13INSLF SEL ATCLV PUCH 200PK
• 20613647000049: 12X18IN SLF SEL ATCLV PCH100PK
• 20613647000032: PUCH SS AUTOCL 5-1/4X10 200/PK
• 00613647000021: PUCH SSL AUTCL 3.5X5.25 200/PK
• 20613647000018: POUCH SSL AUTOCL 3.5X9IN 200PK
• 20613647000001: 10X15INSLF SEL ATCLV PCH 100PK
• 10613647010744: SPOONULA SS 6/PK
• 00613647010662: SPOONULA SS
• 00613647010655: SPOONULA SS
• 00613647010631: SPATULA WEIGHING SS 5 IN
• 00613647010624: SPATULA WEIGHING SS 4 IN
• 00613647010617: SPATULA WEIGHING SS 3 IN
• 00613647010600: HANDI HOLD SPATULA 8 IN
• 00613647010594: HANDI HOLD SPATULA 6 IN
• 00613647010587: HANDI HOLD SPATULA 5 IN
• 00613647010570: HANDI HOLD SPATULA 4 IN
• 00613647010563: HANDI HOLD SPATULA 3 IN
• 00613647010556: SPATULA STAINLESS STEEL 12 IN
• 00613647010549: SPATULA STAINLESS STEEL 10IN
• 00613647010532: SPATULA STAINLESS STEEL 8 IN
• 00613647010525: SPATULA STAINLESS STEEL 6 IN