5mm Atraumatic Grasper S/A, Ratcheting Handle, With Rotation

GUDID 10815288014123

ENCISION, INC.

Rigid endoscopic tissue manipulation forceps, reusable

• Primary Device ID: 10815288014123
• NIH Device Record Key: 4694aa0b-8fc2-4b7d-a724-1cadbbcda759
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 5mm Atraumatic Grasper S/A, Ratcheting Handle, With Rotation
• Version Model Number: EP3460-45RR
• Company DUNS: 612250175
• Company Name: ENCISION, 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815288014123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K925079

FDA Product Code

• HET: Laparoscope, Gynecologic (And Accessories)

Sterilization

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

[10815288014123]

Moist Heat or Steam Sterilization

[10815288014123]

Moist Heat or Steam Sterilization

[10815288014123]

Moist Heat or Steam Sterilization

[10815288014123]

Moist Heat or Steam Sterilization

[10815288014123]

Moist Heat or Steam Sterilization

[10815288014123]

Moist Heat or Steam Sterilization

[10815288014123]

Moist Heat or Steam Sterilization

[10815288014123]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-20
• Device Publish Date: 2021-08-12

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