INSORB REF2030

GUDID 10867516000101

INSORB Subcuticular Skin Stapler REF2030 (each)

INCISIVE SURGICAL, INC.

Skin stapler/staple, bioabsorbable

• Primary Device ID: 10867516000101
• NIH Device Record Key: 12d5ab9c-2728-4bf2-a556-667fd2c6f1ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INSORB
• Version Model Number: 2030
• Catalog Number: REF2030
• Company DUNS: 014099662
• Company Name: INCISIVE 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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 61 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid prolonged exposure to elevated termperatures. Do not expose to temperatures above 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867516000104 [Primary]
GS1	10867516000101 [Package]; Contains: 00867516000104; Package: Carton [6 Units]; In Commercial Distribution

FDA Product Code

• GDW: Staple, Implantable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-14

On-Brand Devices [INSORB]

• 00867516000111: INSORB Subcuticular Skin Stapler REF1008 (each)
• 10867516000101: INSORB Subcuticular Skin Stapler REF2030 (each)