Breast Implant Protector

GUDID 00613244000059

Breast Implant Protector

ADEPT MED INTERNATIONAL INC

Viscera retention paddle Viscera retention paddle Viscera retention paddle Viscera retention paddle Viscera retention paddle Viscera retention paddle Viscera retention paddle Viscera retention paddle Viscera retention paddle Viscera retention paddle Viscera retention paddle Viscera retention paddle Viscera retention paddle Viscera retention paddle Viscera retention paddle Viscera retention paddle Viscera retention paddle

• Primary Device ID: 00613244000059
• NIH Device Record Key: 25e36a33-5491-436b-9ab4-492609ed37ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Breast Implant Protector
• Version Model Number: 3208
• Company DUNS: 044962397
• Company Name: ADEPT MED INTERNATIONAL INC
• Device Count: 10
• 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

Customer Support Contacts

• Phone: 5306211220
• Email: sales@adeptmed.com
• Phone: 5306211220
• Email: sales@adeptmed.com
• Phone: 5306211220
• Email: sales@adeptmed.com
• Phone: 5306211220
• Email: sales@adeptmed.com
• Phone: 5306211220
• Email: sales@adeptmed.com
• Phone: 5306211220
• Email: sales@adeptmed.com
• Phone: 5306211220
• Email: sales@adeptmed.com
• Phone: 5306211220
• Email: sales@adeptmed.com
• Phone: 5306211220
• Email: sales@adeptmed.com
• Phone: 5306211220
• Email: sales@adeptmed.com
• Phone: 5306211220
• Email: sales@adeptmed.com
• Phone: 5306211220
• Email: sales@adeptmed.com
• Phone: 5306211220
• Email: sales@adeptmed.com
• Phone: 5306211220
• Email: sales@adeptmed.com
• Phone: 5306211220
• Email: sales@adeptmed.com
• Phone: 5306211220
• Email: sales@adeptmed.com
• Phone: 5306211220
• Email: sales@adeptmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613244000059 [Primary]
GS1	61324400005900 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K893870

FDA Product Code

• GCZ: Retainer, Surgical

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: 2023-02-24
• Device Publish Date: 2023-02-16

Devices Manufactured by ADEPT MED INTERNATIONAL INC

• 00613244000004 - Viscera Retainer, Fish: 2023-02-24 Medium Viscera Retainer
• 61324400001100 - Viscera Retainer, Fish: 2023-02-24 Pediatric Viscera Retainer
• 61324400002800 - Viscera Retainer, Fish: 2023-02-24 Small Viscera Retainer
• 61324400003500 - Viscera Retainer, Fish: 2023-02-24 Large Viscera Retainer
• 61324400004200 - Viscera Retainer, Fish: 2023-02-24 Extra Large Viscera Retainer
• 00613244000059 - Breast Implant Protector: 2023-02-24Breast Implant Protector
• 00613244000059 - Breast Implant Protector: 2023-02-24 Breast Implant Protector
• 61324400006600 - Viscera Retainer, Fish: 2023-02-24 Jumbo Viscera Retainer