GELITA-SPON® STANDARD

GUDID 04260293130075

The GELITA-SPON® Absorbable Gelatin Sponge, U.S.P. (“Gelita-Spon”) is made of 100% purified porcine gelatine and is of neutral character in nature. GELITA-SPON® Absorbable Gelatin Sponge is non-pyrogenic. It is intended for use to control minimal bleeding by tamponade effect, blood absorption and platelet aggregation following ENT surgery. It is insoluble in water and fully absorbable. Its porous structure and interstices enables the product to absorb more than 35 times its own weight of blood and fluids. The absorptive capacity of GELITA-SPON® is a function of its physical size, increasing as the amount of gelatine increases. It is supplied in several sizes. It is packaged individually in (double) blister, pouch or jar/container packaging, sterilized by gamma rays, and is for single use only.

GELITA MEDICAL GmbH

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• Primary Device ID: 04260293130075
• NIH Device Record Key: a93799fb-3517-4b55-9857-2b6802a2d744
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GELITA-SPON® STANDARD
• Version Model Number: GS-030
• Company DUNS: 330774063
• Company Name: GELITA MEDICAL GmbH
• 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: true
• 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

Device Dimensions

• Length: 80 Millimeter
• Height: 10 Millimeter
• Depth: 40 Millimeter
• Length: 80 Millimeter
• Height: 10 Millimeter
• Depth: 40 Millimeter
• Length: 80 Millimeter
• Height: 10 Millimeter
• Depth: 40 Millimeter
• Length: 80 Millimeter
• Height: 10 Millimeter
• Depth: 40 Millimeter
• Length: 80 Millimeter
• Height: 10 Millimeter
• Depth: 40 Millimeter
• Length: 80 Millimeter
• Height: 10 Millimeter
• Depth: 40 Millimeter
• Length: 80 Millimeter
• Height: 10 Millimeter
• Depth: 40 Millimeter
• Length: 80 Millimeter
• Height: 10 Millimeter
• Depth: 40 Millimeter
• Length: 80 Millimeter
• Height: 10 Millimeter
• Depth: 40 Millimeter
• Length: 80 Millimeter
• Height: 10 Millimeter
• Depth: 40 Millimeter
• Length: 80 Millimeter
• Height: 10 Millimeter
• Depth: 40 Millimeter
• Length: 80 Millimeter
• Height: 10 Millimeter
• Depth: 40 Millimeter
• Length: 80 Millimeter
• Height: 10 Millimeter
• Depth: 40 Millimeter
• Length: 80 Millimeter
• Height: 10 Millimeter
• Depth: 40 Millimeter
• Length: 80 Millimeter
• Height: 10 Millimeter
• Depth: 40 Millimeter
• Length: 80 Millimeter
• Height: 10 Millimeter
• Depth: 40 Millimeter
• Length: 80 Millimeter
• Height: 10 Millimeter
• Depth: 40 Millimeter
• Length: 80 Millimeter
• Height: 10 Millimeter
• Depth: 40 Millimeter
• Length: 80 Millimeter
• Height: 10 Millimeter
• Depth: 40 Millimeter
• Length: 80 Millimeter
• Height: 10 Millimeter
• Depth: 40 Millimeter
• Length: 80 Millimeter
• Height: 10 Millimeter
• Depth: 40 Millimeter
• Length: 80 Millimeter
• Height: 10 Millimeter
• Depth: 40 Millimeter
• Length: 80 Millimeter
• Height: 10 Millimeter
• Depth: 40 Millimeter
• Length: 80 Millimeter
• Height: 10 Millimeter
• Depth: 40 Millimeter
• Length: 80 Millimeter
• Height: 10 Millimeter
• Depth: 40 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, keep dry and away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260293130075 [Package]; Contains: 04260293133076; Package: Suture Box [10 Units]; In Commercial Distribution
GS1	04260293133076 [Primary]
GS1	04260293137074 [Package]; Package: Transport Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060878

FDA Product Code

• LYA: Splint, Intranasal Septal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-05
• Device Publish Date: 2021-07-28

On-Brand Devices [GELITA-SPON® STANDARD]

• 04260293130068: The GELITA-SPON® Absorbable Gelatin Sponge, U.S.P. (“Gelita-Spon”) is made of 100% purified
• 04260293130174: The GELITA-SPON® Absorbable Gelatin Sponge, U.S.P. (“Gelita-Spon”) is made of 100% purified
• 04260293130075: The GELITA-SPON® Absorbable Gelatin Sponge, U.S.P. (“Gelita-Spon”) is made of 100% purified
• 04260293130198: The GELITA-SPON® Absorbable Gelatin Sponge, U.S.P. (“Gelita-Spon”) is made of 100% purified
• 04260293130143: The GELITA-SPON® Absorbable Gelatin Sponge, U.S.P. (“Gelita-Spon”) is made of 100% purified
• 04260293130105: The GELITA-SPON® Absorbable Gelatin Sponge, U.S.P. (“Gelita-Spon”) is made of 100% purified
• 04260293133083: The GELITA-SPON® Absorbable Gelatin Sponge, U.S.P. (“Gelita-Spon”) is made of 100% purified