- Physicians Office Resource

HISTOACRYL FLEXIBLE PACK 5
AESCULAP - 1051250P

Device Description

A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Environmental Conditions

Storage Environment Temperature - Degrees Celsius

25.00
0.00

Device Sizes

Raw material : n-butyl-2-cyanoacrylate

Volume : 0.500 ML

Raw material : n-butyl-2-cyanoacrylate
Volume : 0.500 ML

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: MPN

Device Name: Tissue Adhesive For The Topical Approximation Of Skin

Device Class: 2

Physical State: N/A

Definition: Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k).

Submission Type ID: 1

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 878.4010

Third Party Flag: N

Medical Specialty: SU

Device Identifiers

Device Id: 04046964050947

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Device Id: 04046964050930

Device Type: Unit of Use

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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