4116

GUDID 10888551010313

KNIFE SET ECTRA II (PACK OF 3)

STERILMED, INC.

Surgical saw blade, reciprocating, single-use

• Primary Device ID: 10888551010313
• NIH Device Record Key: 1dfd2eed-1768-4b1d-9a70-1e37811f0581
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: DYO4116
• Catalog Number: 4116
• Company DUNS: 175899459
• Company Name: STERILMED, INC.
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: true
• 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(888)541-0078
• Email: sterilmedcs@its.jnj.com
• Phone: +1(888)541-0078
• Email: sterilmedcs@its.jnj.com
• Phone: +1(888)541-0078
• Email: sterilmedcs@its.jnj.com
• Phone: +1(888)541-0078
• Email: sterilmedcs@its.jnj.com
• Phone: +1(888)541-0078
• Email: sterilmedcs@its.jnj.com
• Phone: +1(888)541-0078
• Email: sterilmedcs@its.jnj.com
• Phone: +1(888)541-0078
• Email: sterilmedcs@its.jnj.com
• Phone: +1(888)541-0078
• Email: sterilmedcs@its.jnj.com
• Phone: +1(888)541-0078
• Email: sterilmedcs@its.jnj.com
• Phone: +1(888)541-0078
• Email: sterilmedcs@its.jnj.com
• Phone: +1(888)541-0078
• Email: sterilmedcs@its.jnj.com
• Phone: +1(888)541-0078
• Email: sterilmedcs@its.jnj.com
• Phone: +1(888)541-0078
• Email: sterilmedcs@its.jnj.com
• Phone: +1(888)541-0078
• Email: sterilmedcs@its.jnj.com
• Phone: +1(888)541-0078
• Email: sterilmedcs@its.jnj.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888551010313 [Primary]
GS1	80888551010312 [Unit of Use]

FDA Product Code

• HTS: KNIFE, ORTHOPEDIC

Sterilization

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

[10888551010313]

Ethylene Oxide

[10888551010313]

Ethylene Oxide

[10888551010313]

Ethylene Oxide

[10888551010313]

Ethylene Oxide

[10888551010313]

Ethylene Oxide

[10888551010313]

Ethylene Oxide

[10888551010313]

Ethylene Oxide

[10888551010313]

Ethylene Oxide

[10888551010313]

Ethylene Oxide

[10888551010313]

Ethylene Oxide

[10888551010313]

Ethylene Oxide

[10888551010313]

Ethylene Oxide

[10888551010313]

Ethylene Oxide

[10888551010313]

Ethylene Oxide

[10888551010313]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-01-22
• Device Publish Date: 2019-08-13

Devices Manufactured by STERILMED, INC.

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• 10888551045704 - Reprocessed DECANAV EP Catheter, F Curve: 2024-11-25 Reprocessed DECANAV EP Catheter, F Curve, 7Fr, 115cm, Electrodes: 11, SP:2-8-2mm, Tip Length: 2.4mm, Pin Connector:34
• 10888551045179 - NA: 2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, F CURVE
• 10888551045186 - NA: 2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, D CURVE
• 10888551045193 - NA: 2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, F CURVE
• 10888551045209 - NA: 2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, D CURVE
• 10888551010313 - NA: 2021-01-22KNIFE SET ECTRA II (PACK OF 3)
• 10888551010313 - NA: 2021-01-22 KNIFE SET ECTRA II (PACK OF 3)
• 10888551021531 - NA: 2021-01-22 KNIVES (1) HOOK BLADE (1) TRIANGLE BLADE ENDOTRAC BLADE SYSTEM