DropSafe™ Inject-Safe Barrier Bandage™ 6070

GUDID 15907996099976

Barrier Bandage it’s intended to contain post-injection bleeding during a subcutaneous or intramuscular injection. The device is intended for healthcare professions (HCP) and lay users. The device is an OTC product.

HTL STREFA S A

Skin adhesive protective material

• Primary Device ID: 15907996099976
• NIH Device Record Key: f25435b0-0849-490a-8ac8-9dd463d4b0b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DropSafe™ Inject-Safe Barrier Bandage™
• Version Model Number: n/a
• Catalog Number: 6070
• Company DUNS: 422528088
• Company Name: HTL STREFA S A
• Device Count: 100
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	05907996099979 [Primary]
GS1	15907996099976 [Package]; Contains: 05907996099979; Package: shipper box [20 Units]; In Commercial Distribution
GS1	85907996099975 [Unit of Use]

FDA Product Code

• KGX: Tape And Bandage, Adhesive

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: 2023-07-03
• Device Publish Date: 2023-06-25

Devices Manufactured by HTL STREFA S A

• 50096295142995 - LEADER, pen needles: 2024-01-25 LEADER pen needles are sterile, single-use pen needles intended for use with pen injector devicec for the subcutaneous injection
• 10096295143000 - LEADER, pen needles: 2024-01-25 LEADER pen needles are sterile, single-use pen needles intended for use with pen injector devicec for the subcutaneous injection
• 15907996099976 - DropSafe™ Inject-Safe Barrier Bandage™: 2023-07-03Barrier Bandage it’s intended to contain post-injection bleeding during a subcutaneous or intramuscular injection. The device is intended for healthcare professions (HCP) and lay users. The device is an OTC product.
• 15907996099976 - DropSafe™ Inject-Safe Barrier Bandage™: 2023-07-03 Barrier Bandage it’s intended to contain post-injection bleeding during a subcutaneous or intramuscular injection. The device
• 15903999603080 - Safe-T-Lance Plus, safety lancets: 2023-04-06 Safety lancets are sterile, single use medical devices intended for capillary blood sampling. Intended users are healthcare prof
• 15903999603097 - Safe-T-Lance Plus, safety lancets: 2023-04-06 Safety lancets are sterile, single use medical devices intended for capillary blood sampling. Intended users are healthcare prof
• 15903999603103 - Safe-T-Lance Plus, safety lancets: 2023-04-06 Safety lancets are sterile, single use medical devices intended for capillary blood sampling. Intended users are healthcare prof
• 15903999603110 - Safe-T-Lance Plus, safety lancets: 2023-04-06 Safety lancets are sterile, single use medical devices intended for capillary blood sampling. Intended users are healthcare prof
• 15903999603127 - Safe-T-Lance Plus, safety lancets: 2023-04-06 Safety lancets are sterile, single use medical devices intended for capillary blood sampling. Intended users are healthcare prof