Integra® CEV8538TU

GUDID 10381780428909

Needle holder insert with carbide left curved jaws for tube 5mm diam., 210mm length

INTEGRA MICROFRANCE

Laparoscopic grasping forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable

• Primary Device ID: 10381780428909
• NIH Device Record Key: 764df133-7002-4730-8990-04a712e75e1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra®
• Version Model Number: CEV8538TU
• Catalog Number: CEV8538TU
• Company DUNS: 276593071
• Company Name: INTEGRA MICROFRANCE
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780428909 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080257

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

[10381780428909]

Moist Heat or Steam Sterilization

[10381780428909]

Moist Heat or Steam Sterilization

[10381780428909]

Moist Heat or Steam Sterilization

[10381780428909]

Moist Heat or Steam Sterilization

[10381780428909]

Moist Heat or Steam Sterilization

[10381780428909]

Moist Heat or Steam Sterilization

[10381780428909]

Moist Heat or Steam Sterilization

[10381780428909]

Moist Heat or Steam Sterilization

[10381780428909]

Moist Heat or Steam Sterilization

[10381780428909]

Moist Heat or Steam Sterilization

[10381780428909]

Moist Heat or Steam Sterilization

[10381780428909]

Moist Heat or Steam Sterilization

[10381780428909]

Moist Heat or Steam Sterilization

[10381780428909]

Moist Heat or Steam Sterilization

[10381780428909]

Moist Heat or Steam Sterilization

[10381780428909]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-12
• Device Publish Date: 2019-04-04

On-Brand Devices [Integra®]

• 10381780429425: Fenestrated jaws insert, double-action, 15x5mm jaws, for tube 5mm diam., 410mm length
• 10381780429418: Fenestrated insert, 45mm jaws, for tube 5mm diam., 410mm length
• 10381780429401: Needle holder insert tin corated diam. 5mm, 410mm length
• 10381780429395: SHEATH DIA5MM 410MM FOR TUBE CEV9649B5U (PK3)
• 10381780429388: Delaitre dissector insert, large curved 20mm jaws, for tube 5mm diam., 410mm length
• 10381780429371: Dissector insert, medium curved 20mm jaws, for tube 5mm diam., 410mm length
• 10381780429364: Fenestrated insert, double-action 20mm jaws, for tube 5mm diam., 410mm length
• 10381780429357: Bertrand fenestrated insert, curved 20mm jaws, for tube 5mm diam., 410mm length
• 10381780429340: Fenestrated insert jaws, 20mm tips, for tube 5mm diam., 410mm length
• 10381780429333: Serrated jaws insert for tube 5mm diam., 410mm length
• 10381780429326: Straight scissors insert for tube 5mm diam., 410mm length
• 10381780429319: Alligator insert, 20mm jaws, for tube 5mm diam., 410mm length
• 10381780429302: Dolphin insert, 20mm jaws, for tube 5mm diam., 410mm length
• 10381780429296: Alligator insert, 15mm jaws, for tube 5mm diam., 410mm length
• 10381780429289: Alligator insert, 10mm jaws, for tube 5mm diam., 410mm length
• 10381780429272: Cobra insert with double-action jaws for tube 5mm diam., 410mm length
• 10381780429265: Grasping insert for tube 5mm diam., 410mm length
• 10381780429258: Wire insert for jaws CEV607U CEV607CU CEV607DU, 410mm
• 10381780429241: Very curved insulated titanium scissors insert for tube diam. 5mm, 410mm length
• 10381780429234: Very curved insulated scissors insert for tube 5mm diam., 410mm length (3/pk)
• 10381780429227: Very curved scissors insert for tube 5mm diam., 410mm length
• 10381780429210: Curved scissors insert for tube 5mm diam., 410mm length
• 10381780429203: Cau needle holder insert, right curved jaws, for tube 5mm diam., 410mm length
• 10381780429197: Needle holder insert, carbide straight jaws, for tube 5mm diam., 410mm length
• 10381780429180: Knot guide scissors insert for tube 5mm diam., 410mm length
• 10381780429173: Demaizieres fenestrated insert, 20x3mm jaws, for tube 5mm diam., 410mm length
• 10381780429166: Oval curette insert for tube 5mm diam., 410mm length
• 10381780429159: Straight scissors insert with serrated blades for tube 5mm diam., 410mm length
• 10381780429142: Fenestrated jaws insert, double-action, 15x5mm jaws, for tube 5mm diam., 210mm length
• 10381780429135: Fenestrated insert, 45mm jaws, for tube 5mm diam., 210mm length
• 10381780429128: Needle holder insert tin corated diam. 5mm, 210 mm length
• 10381780429111: SHEATH DIA5MM 210MM FOR TUBE CEV649B5U (PK3)
• 10381780429104: Delaitre dissector insert, large curved 20mm jaws, for tube 5mm diam., 210mm length
• 10381780429098: Dissector insert, medium curved 20mm jaws for tube 5mm diam., 210mm length
• 10381780429081: Fenestrated insert, smooth 20mm jaws, for tube 5mm diam., 210mm length
• 10381780429074: Fenestrated insert, double-action 20mm jaws, for tube 5mm diam., 210mm length
• 10381780429067: Bertrand fenestrated insert, curved 20mm jaws, for tube 5mm diam., 210mm length
• 10381780429050: Fenestrated insert, 20mm jaws, for tube 5mm diam., 210mm length
• 10381780429043: Serrated jaws insert for tube 5mm diam., 210mm length
• 10381780429036: Straight scissors insert for tube 5mm diam., 210mm length
• 10381780429029: Babcock insert for tube 5mm diam., 210mm length
• 10381780429012: Fenestrated insert, 20mm jaws with teeth, for tube 5mm diam., 210mm length
• 10381780429005: Alligator insert, 15mm jaws, for tube 5mm diam., 210mm length
• 10381780428992: Tiger insert for tube 5mm diam., 210mm length
• 10381780428985: Cobra insert double-action jaws for tube 5mm diam., 210mm length
• 10381780428978: Grasping insert for tube 5mm diam., 210mm length
• 10381780428961: Wire insert for jaws CEV607U CEV607CU CEV607Du, 210mm length
• 10381780428954: Very curved insulated titanium scissors insert for tube diam. 5mm, 210mm length
• 10381780428947: Very curved insulated scissors insert for tube 5mm diam., 210mm length (3/pk)
• 10381780428930: Very curved scissors insert for tube 5mm diam., 210mm length