EARLOOP FACE MASK PINK 3 PLY (2116)

GUDID 00303620000307

FACEMASK PINK E/L

SEPTODONT, INC

Surgical/medical face mask, single-use

• Primary Device ID: 00303620000307
• NIH Device Record Key: cdda857d-5aa7-4556-832e-0860cda30f8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EARLOOP FACE MASK PINK 3 PLY (2116)
• Version Model Number: 01I2116
• Company DUNS: 012925513
• Company Name: SEPTODONT, INC
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00303620000307 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051291

FDA Product Code

• FXX: Mask, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-09-12

Devices Manufactured by SEPTODONT, INC

• 13760140703608 - R.T.R Membrane: 2021-02-08 Absorbable Collagen Membrane (15X20MM) for dental surgery.
• 03760140703618 - R.T.R Membrane: 2021-02-08 Absorbable Collagen Membrane (20X30MM) for dental surgery
• 13760140703622 - R.T.R Membrane: 2021-02-08 Absorbable Collagen Membrane (30X40MM) for dental surgery.
• 00303620000291 - EARLOOP FACE MASK BLUE 3 PLY (2115): 2020-05-06 FACEMASK BLUE E/L
• 00303620000307 - EARLOOP FACE MASK PINK 3 PLY (2116): 2020-05-06FACEMASK PINK E/L
• 00303620000307 - EARLOOP FACE MASK PINK 3 PLY (2116): 2020-05-06 FACEMASK PINK E/L
• 00303620000314 - EARLOOP FACE MASK WHITE 3 PLY (2130): 2020-05-06 MASK E/L WH L1
• 00303620000109 - 2 INCH CLEAR CONT NYL FILM (0002): 2019-11-08 2 INCH CLEAR CONT NYL FILM (0002)
• 00303620000116 - 3 INCH CLEAR CONT NYLON FILM (0003): 2019-11-08 3 INCH CLEAR CONT NYLON FILM (0003)