Miltex® 62508

GUDID H834625081

18" SZ3-0 SLK BLK NON-ABS C-6 NEEDLE CIR REV CUT

INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Silk suture, sterile

• Primary Device ID: H834625081
• NIH Device Record Key: bf3040e7-e1b6-4cfe-8637-69f6c85cd618
• Commercial Distribution Discontinuation: 2016-12-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Miltex®
• Version Model Number: 62508
• Catalog Number: 62508
• Company DUNS: 081277700
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Device Count: 12
• 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: 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00381780038453 [Unit of Use]
GS1	10381780038450 [Primary]
HIBCC	H834625081 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020901

FDA Product Code

• GAP: SUTURE, NONABSORBABLE, SILK

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-05
• Device Publish Date: 2015-09-22

On-Brand Devices [Miltex®]

• 10381780363927: 27" SZ 5-0 VIOLT PGA ABS C-6 NEEDLE CIR REV CUT
• 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
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• 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)