Miltex®

GUDID H834357011

Laparoscopic Luer Lock Lanyard Replacement Snap-On Cap

INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope

• Primary Device ID: H834357011
• NIH Device Record Key: 31b2a130-fc56-472e-8aed-d98e3f14d1c8
• Commercial Distribution Discontinuation: 2019-10-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Miltex®
• Version Model Number: 35-701
• Company DUNS: 081277700
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• 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: false
• 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
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780251187 [Primary]
HIBCC	H834357011 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941541

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

[H834357011]

Moist Heat or Steam Sterilization

[H834357011]

Moist Heat or Steam Sterilization

[H834357011]

Moist Heat or Steam Sterilization

[H834357011]

Moist Heat or Steam Sterilization

[H834357011]

Moist Heat or Steam Sterilization

[H834357011]

Moist Heat or Steam Sterilization

[H834357011]

Moist Heat or Steam Sterilization

[H834357011]

Moist Heat or Steam Sterilization

[H834357011]

Moist Heat or Steam Sterilization

[H834357011]

Moist Heat or Steam Sterilization

[H834357011]

Moist Heat or Steam Sterilization

[H834357011]

Moist Heat or Steam Sterilization

[H834357011]

Moist Heat or Steam Sterilization

[H834357011]

Moist Heat or Steam Sterilization

[H834357011]

Moist Heat or Steam Sterilization

[H834357011]

Moist Heat or Steam Sterilization

[H834357011]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-05
• Device Publish Date: 2016-08-23

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• 10381780363910: 27" SZ 4-0 VIOLT PGA ABS C-6 NEEDLE CIR REV CUT
• 10381780363903: 27" SZ 3-0 VIOLT PGA ABS C-6 NEEDLE CIR REV CUT
• 10381780363897: 18" SZ3-0 SLK BLK NON-ABS C-9 NEEDLE CIR REV CUT
• 10381780363880: 18" SZ4-0 SLK BLK NON-ABS C-6 NEEDLE CIR REV CUT
• 10381780363873: 18" SZ3-0 SLK BLK NON-ABS C-6 NEEDLE CIR REV CUT
• 10381780363866: 18" SZ 3-0 PLAIN GUT ABS C-7 NEEDLE CIR REV CUT
• 10381780363859: 27" SZ 4-0 PLAIN GUT ABS C-6 NEEDLE CIR REV CUT
• 10381780363842: 18" SZ 4-0 PLAIN GUT ABS C-6 NEEDLE CIR REV CUT
• 10381780363835: 18" SZ 3-0 PLAIN GUT ABS C-6 NEEDLE CIR REV CUT
• 10381780363828: 18" SZ 3-0 PLAIN GUT ABS C-3 CIR PREM REV CUT
• 10381780363811: 18" SZ 3-0 CHRMIC GUT ABS C-6 NEEDLE CIR REV CUT
• 10381780363804: 18" SZ 4-0 CHRMIC GUT ABS C-6 NEEDLE CIR REV CUT
• 10381780363798: 18" SZ 5-0 CHRMIC GUT ABS C-3 CIR PREM REV CUT
• H834309751: Duplay Uterine Tenaculum Forceps, double curved
• H834283701: Buie Rectal Suction Tube with finger valve
• H834357011: Laparoscopic Luer Lock Lanyard Replacement Snap-On Cap
• H834357001: Laparoscopic Luer Lock Replacement Screw-On Cap
• H834MH72591: Gemini-Mixter Hemostatic Forceps, delicate, full curved jaws
• H834MH72581: Gemini-Mixter Hemostatic Forceps, delicate, full curved jaws
• H834MH72571: Gemini-Mixter Hemostatic Forceps, delicate, full curved jaws
• H834MH72561: Gemini-Mixter Hemostatic Forceps, delicate, full curved jaws
• H834MH72551: Gemini-Mixter Hemostatic Forceps, delicate, full curved jaws
• H834231251SS0: JACKSON TRACH SHORT SZ 10 (7034620)
• H834231250SS0: JACKSON TRACH SHORT SZ 9 (7034619)
• H834231249SS0: JACKSON TRACH SHORT SZ 8 (7034618)
• H834231247SS0: JACKSON TRACH SHORT SZ 6 (7034616)
• H834231246SS0: JACKSON TRACH SHORT SZ 5 (7034615)
• H834231245SS0: JACKSON TRACH SHORT SZ 4 (7034614)
• H834231243SS0: JACKSON TRACH SHORT SZ 2 (7034612)
• H834231219SS0: JACKSON TRACH SZ 10 REG (7034320)
• H834231218SS0: JACKSON TRACH SZ 9 REG (7034319)
• H834231216SS0: JACKSON TRACH SZ 8 REG (7034318)
• H834231214SS0: JACKSON TRACH SZ 7 REG (7034317)
• H834231212SS0: JACKSON TRACH SZ 6 REG (7034316)
• H834231210SS0: JACKSON TRACH SZ 5 REG (7034315)
• H834231208SS0: JACKSON TRACH SZ 4 REG (7034314)
• H834231206SS0: JACKSON TRACH SZ 3 REG (7034313)
• H834231204SS0: JACKSON TRACH SZ 2 REG (7034312)
• H834231202SS0: JACKSON TRACH SZ 1 REG (7034311)
• H834231200SS0: JACKSON TRACH SZ 0 REG (7034310)
• H834231199SS0: JACKSON TRACHEA TUBE 00 (7034300)
• H834231159SS0: JACKSON TRACH TUBE SZ 10 (7034920)
• H834231158SS0: JACKSON TRACH TUBE SZ 9 (7034919)
• H834231156SS0: JACKSON TRACH TUBE SZ 8 (7034918)
• H834231154SS0: JACKSON TRACH TUBE SZ 7 (7034917)
• H834231152SS0: JACKSON TRACH TUBE SZ 6 (7034916)
• H834231150SS0: JACKSON TRACH TUBE SZ 5 (7034915)
• H834231148SS0: JACKSON TRACH TUBE SZ 4 (7034914)
• H834231144SS0: JACKSON TRACH TUBE SZ 2 (7034912)