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 Skin adhesive protective material Skin adhesive protective material Skin adhesive protective material Skin adhesive protective material Skin adhesive protective material Skin adhesive protective material Skin adhesive protective material Skin adhesive protective material Skin adhesive protective material Skin adhesive protective material Skin adhesive protective material Skin adhesive protective material Skin adhesive protective material Skin adhesive protective material Skin adhesive protective material 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