Carerite®

GUDID 07290016678116

4" Sterilization Tubing Perf Ind

STEPAC L.A. LTD.

Sterilization packaging, single-use

• Primary Device ID: 07290016678116
• NIH Device Record Key: 254aaa57-59f4-4ba6-8f7f-4eed3db87a14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Carerite®
• Version Model Number: 1
• Company DUNS: 600402291
• Company Name: STEPAC L.A. LTD.
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016678116 [Primary]
GS1	17290016678113 [Package]; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K870147

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: 2017-08-18

On-Brand Devices [Carerite®]

• 00729001667806: 3" Sterilization Tubing Cont Ind
• 07290016678161: 6" Nylon Sterilization Pouch
• 07290016678154: 4" Nylon Sterilization Pouch
• 07290016678147: 3" Nylon Sterilization Pouch
• 07290016678130: 2" Nylon Sterilization Pouch
• 07290016678123: 6" Sterilization Tubing Perf Ind
• 07290016678116: 4" Sterilization Tubing Perf Ind
• 07290016678109: 3" Sterilization Tubing Perf Ind
• 07290016678093: 2" Sterilization Tubing Perf Ind
• 07290016678086: 6" Sterilization Tubing Cont Ind
• 07290016678079: 4" Sterilization Tubing Cont Ind
• 17290016678069: 3" Sterilization Tubing Cont Ind
• 07290016678055: 2" Sterilization Tubing Cont Ind
• 07290016678048: 6" Sterilization Tubing Cont Clr
• 07290016678031: 4" Sterilization Tubing Cont Clr
• 07290016678024: 3" Sterilization Tubing Cont Clr
• 07290016678017: 2" Sterilization Tubing Cont Clr