Wexler Surgical, Inc.

GUDID M944SL86281FP0

WEXLER SURGICAL, INC.

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• Primary Device ID: M944SL86281FP0
• NIH Device Record Key: 346b9f34-b23d-46b2-9f59-65dcb82038a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wexler Surgical, Inc.
• Version Model Number: SL8628.1-FP
• Company DUNS: 024882552
• Company Name: WEXLER SURGICAL, 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M944SL86281FP0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110121

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

[M944SL86281FP0]

Moist Heat or Steam Sterilization

[M944SL86281FP0]

Moist Heat or Steam Sterilization

[M944SL86281FP0]

Moist Heat or Steam Sterilization

[M944SL86281FP0]

Moist Heat or Steam Sterilization

[M944SL86281FP0]

Moist Heat or Steam Sterilization

[M944SL86281FP0]

Moist Heat or Steam Sterilization

[M944SL86281FP0]

Moist Heat or Steam Sterilization

[M944SL86281FP0]

Moist Heat or Steam Sterilization

[M944SL86281FP0]

Moist Heat or Steam Sterilization

[M944SL86281FP0]

Moist Heat or Steam Sterilization

[M944SL86281FP0]

Moist Heat or Steam Sterilization

[M944SL86281FP0]

Moist Heat or Steam Sterilization

[M944SL86281FP0]

Moist Heat or Steam Sterilization

[M944SL86281FP0]

Moist Heat or Steam Sterilization

[M944SL86281FP0]

Moist Heat or Steam Sterilization

[M944SL86281FP0]

Moist Heat or Steam Sterilization

[M944SL86281FP0]

Moist Heat or Steam Sterilization

[M944SL86281FP0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-07-01
• Device Publish Date: 2018-09-23

On-Brand Devices [Wexler Surgical, Inc.]

• M944VL021240: VL0212.4
• M944VL021140: VL0211.4
• M944VL020640: VL0206.4
• M944VL020540: VL0205.4
• M944VL020240: VL0202.4
• M944VL020140: VL0201.4
• M944CL023810: CL0238.1
• M944CL023610: CL0236.1
• M944CL023410: CL0234.1
• M944CL023210: CL0232.1
• M944CL023010: CL0230.1
• M944CL014210: CL0142.1
• M944CL014010: CL0140.1
• M944CL013910: CL0139.1
• M944CL013810: CL0138.1
• M944CL013610: CL0136.1
• M944CL013510: CL0135.1
• M944CL013410: CL0134.1
• M944CL013210: CL0132.1
• M944CL013110: CL0131.1
• M944CL013010: CL0130.1
• M944CL012710: CL0127.1
• M944CL012610: CL0126.1
• M944CL012510: CL0125.1
• M944CL012410: CL0124.1
• M944CL012210: CL0122.1
• M944CL012110: CL0121.1
• M944CL012010: CL0120.1
• M944CL011910: CL0119.1
• M944CL011810: CL0118.1
• M944CL011710: CL0117.1
• M944CL011610: CL0116.1
• M944CL011510: CL0115.1
• M944CL011410: CL0114.1
• M944CL011310: CL0113.1
• M944CL011210: CL0112.1
• M944CL011010: CL0110.1
• M944CL010910: CL0109.1
• M944CL010610: CL0106.1
• M944CL010510: CL0105.1
• M944CL010210: CL0102.1
• M944CL010110: CL0101.1
• M944CL009910: CL0099.1
• M944CL009810: CL0098.1
• M944CL009710: CL0097.1
• M944CL009610: CL0096.1
• M944CL009410: CL0094.1
• M944CL009210: CL0092.1
• M944CL009010: CL0090.1
• M944CL008810: CL0088.1