CCORE 19312

GUDID 00817602023333

Craniotomy Incise Drape

EXACT MEDICAL MANUFACTURING, INC.

Patient surgical drape, single-use

• Primary Device ID: 00817602023333
• NIH Device Record Key: 19e6d090-363d-40fc-92c8-c2d34fa48f7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CCORE
• Version Model Number: 19312
• Catalog Number: 19312
• Company DUNS: 014464314
• Company Name: EXACT MEDICAL MANUFACTURING, INC.
• Device Count: 1
• DM Exempt: false
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817602023173 [Primary]
GS1	00817602023333 [Package]; Contains: 00817602023173; Package: CASE [15 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101598

FDA Product Code

• KKX: Drape, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-02-05
• Device Publish Date: 2020-11-10

On-Brand Devices [CCORE]

• 10817602023071: Pack, Surgical Procedure, Lithotomy
• 10817602023064: Pack, Surgical Procedure, Peri-Gyn
• 00817602023050: Pack, Surgical Procedure, Cysto w Leggings
• 00817602023036: Pack, Surgical Procedure, Shoulder Arthroscopy
• 00817602023012: Pack, Surgical Procedure, Laparotomy
• 00817602022992: Drape, Surgical, Shoulder Split
• 00817602022978: Drape, Surgical, Extremity
• 00817602022954: Drape, Surgical, UBD, Impervious
• 00817602022930: Drape, Surgical, Laparotomy Ped
• 00817602022916: Drape, Surgical, Lithotomy
• 00817602022893: Drape Sheet, Surgical T, Laparotomy
• 00817602022879: Drape, Mayo Stand XL
• 00817602022855: Drape Spilt Sheet
• 10817602022838: Drape, Surgical Leggings
• 00817602022824: Drape, Surgical, Endoscopic
• 00817602022800: Drape, Surgical, Lap Chole
• 00817602022787: Drape, Surgical, Utility Tracheostomy
• 00817602022763: Drape, Surgical , Arthroscopy
• 00817602022749: Drape, Surgical Orthopedic, Hand/Foot
• 00817602022725: Drape, Surgical Neck/Thyroid
• 00817602022701: Drape, Tranverse Laparotomy
• 00817602022688: Drape, Surgical Ortho Incise
• 00817602023319: Ophthalmic Drape
• 00817602023302: Laparoscopy Perineal Drape
• 00817602023425: Ortho Universal Split Drape
• 00817602023364: Arthroscopic Drape
• 00817602023418: Ortho Extremity Drape
• 00817602023449: Femoral Angiography Drape 84"x159"
• 00817602023401: Cardio Drape
• 00817602023357: Orthopedic Drape
• 00817602023340: Abdominal Laparoscopy Drape
• 00817602023333: Craniotomy Incise Drape
• 00817602023432: Drape, Transparent Craniotomy incise
• 00817602023395: Cardio Peri Groin Surgical Drape
• 00817602023296: Angiography Surgical Drape
• 00817602023388: Angiography Surgical Drape
• 00817602023326: Back Table Cover 80" x 90"
• 00817602023371: Cesarean Section Surgical Drape
• 00817602023289: Stockinette Reinf. 12"x 48"
• 00817602023272: Orthopedic Stockinette Med.