ESTEEM SYN POST OP KIT STER 409345

GUDID 00768455105328

ESTEEM SYN POST OP KIT STER

CONVATEC, PURCHASING DEPARTMENT

Multiple-piece intestinal ostomy bag, open-ended

• Primary Device ID: 00768455105328
• NIH Device Record Key: 7577d1a1-657b-4f8f-84ea-2c5de8b30577
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESTEEM SYN POST OP KIT STER
• Version Model Number: 409345
• Catalog Number: 409345
• Company DUNS: 809784593
• Company Name: CONVATEC, PURCHASING DEPARTMENT
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00768455105328 [Primary]
GS1	08768455105320 [Unit of Use]
GS1	10768455105325 [Package]; Package: Case [4 Units]; In Commercial Distribution

FDA Product Code

• FON: Bag, Drainage, With Adhesive, Ostomy

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-12-11
• Device Publish Date: 2016-09-01

Devices Manufactured by CONVATEC, PURCHASING DEPARTMENT

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• 10768455209511 - ESENTA: 2024-09-03 ESENTA THIN CURVE 3X9CM (1X80PK) NAI
• 00768455204793 - GENTLECATH: 2024-04-15 GENTLECATH AIR FEM V2.0 CH10 1X30PK US
• 00768455204823 - GENTLECATH: 2024-04-15 GENTLECATH AIR FEM V2.0 CH12 1X30PK US
• 00768455204854 - GENTLECATH: 2024-04-15 GENTLECATH AIR FEM V2.0 CH14 1X30PK US
• 00768455207145 - GENTLECATH: 2024-04-15 GENTLECATH AIR FEM V2.0 CH10 1X10PK US
• 00768455207169 - GENTLECATH: 2024-04-15 GENTLECATH AIR FEM V2.0 CH12 1X10PK US