Getinge Pack Self-Seal Sterilization Pouch 9cm x 23cm 6005500042

GUDID 20814434020626

STERITEC PRODUCT MFG. CO., INC.

Sterilization packaging, single-use

• Primary Device ID: 20814434020626
• NIH Device Record Key: c677a8e9-b974-44a5-b2a2-1deb99cb03a3
• Commercial Distribution Discontinuation: 2016-09-23
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Getinge Pack Self-Seal Sterilization Pouch 9cm x 23cm
• Version Model Number: 6005500042
• Catalog Number: 6005500042
• Company DUNS: 622223196
• Company Name: STERITEC PRODUCT MFG. CO., 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814434020622 [Primary]
GS1	10814434020629 [Package]; Contains: 00814434020622; Package: Bag [200 Units]; Discontinued: 2016-09-23; Not in Commercial Distribution
GS1	20814434020626 [Package]; Contains: 10814434020629; Package: Case [14 Units]; Discontinued: 2016-09-23; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152669

FDA Product Code

• FRG: Wrap, Sterilization

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-09-23

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• 20814434020626 - Getinge Pack Self-Seal Sterilization Pouch 9cm x 23cm: 2019-11-08