ATOMO

GUDID D883AA01131

ATOMO sterilization pouch 3-1/2"x10"

ATOMO DENTAL, INC.

Sterilization packaging, single-use

• Primary Device ID: D883AA01131
• NIH Device Record Key: 79e349fe-793b-45fd-912e-4be5f648bdd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATOMO
• Version Model Number: AA0113
• Company DUNS: 088480717
• Company Name: ATOMO DENTAL, INC.
• Device Count: 200
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	D883AA01130 [Unit of Use]
HIBCC	D883AA01131 [Primary]
HIBCC	D883AA01133 [Package]; Package: Carton [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071886

FDA Product Code

• FRG: Wrap, Sterilization

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-01-08

On-Brand Devices [ATOMO]

• D883AA01181: ATOMO sterilization pouch 4-1/4"x13"
• D883AA01171: ATOMO sterilization pouch 12"x19"
• D883AA01161: ATOMO sterilization pouch 10"x15-1/2"
• D883AA01151: ATOMO sterilization pouch 7-1/2"x14"
• D883AA01141: ATOMO sterilization pouch 5-1/4"x11"
• D883AA01131: ATOMO sterilization pouch 3-1/2"x10"
• D883AA01121: ATOMO sterilization pouch 3-1/2"x6-1/2"
• D883AA01111: ATOMO sterilization pouch 2-3/4"x10"
• D883AA01101: ATOMO sterilization pouch 2-1/4"x5"
• D883AA00843: ATOMO nitrile exam glove, 4.2g, size-XL
• D883AA00833: ATOMO nitrile exam glove, 4.2g, size-L
• D883AA00823: ATOMO nitrile exam glove, 4.2g, size-M
• D883AA00813: ATOMO nitrile exam glove, 4.2g, size-S
• D883AA00803: ATOMO nitrile exam glove, 4.2g, size-XS
• D883AA00743: ATOMO nitrile exam glove, size-XL
• D883AA00733: ATOMO nitrile exam glove, size-L
• D883AA00723: ATOMO nitrile exam glove, size-M
• D883AA00713: ATOMO nitrile exam glove, size-S
• D883AA00703: ATOMO nitrile exam glove, size-XS
• D883AA08153: ATOMO face mask, blue, #2
• D883AA08393: ATOMO kn95 face mask, white, #1
• D883AA08353: ATOMO face mask, blue, #3
• D883AA08323: ATOMO kn95 face mask, white, #2
• D883AA12473: ATOMO Sensor Sleeves, #5
• D883AA12463: ATOMO Sensor Sleeves, #4
• D883AA12433: ATOMO Sensor Sleeves, #3
• D883AA12423: ATOMO Sensor Sleeves, #2
• D883AA12403: ATOMO Sensor Sleeves, #1
• D883AA04313: ATOMO saliva ejector, white
• D883AA04303: ATOMO saliva ejector, blue
• D883AA04273: ATOMO Surgical Aspirator Tips, Large
• D883AA04263: ATOMO Surgical Aspirator Tips, Standard
• D883AA04253: ATOMO Surgical Aspirator Tips, Small
• D883AA04203: ATOMO High-Volume Evacuator Tip
• D883AA02503: ATOMO Intraoral Camera Sheath
• D883AA08253: ATOMO Bite Registration Tray, Posterior Sideless
• D883AA08243: ATOMO Bite Registration Tray, Posterior
• D883AA08233: ATOMO Bite Registration Tray, Quadrant
• D883AA08223: ATOMO Bite Registration Tray, Anterior
• D883AA08213: ATOMO Bite Registration Tray, Full Arch
• D883AA08103: ATOMO Disposable Impression Trays, Anterior Lower
• D883AA08093: ATOMO Disposable Impression Trays, Anterior Upper
• D883AA08083: ATOMO Disposable Impression Trays, Quadrant Upper Right / Lower Left
• D883AA08073: ATOMO Disposable Impression Trays, Quadrant Upper Left / Lower Right
• D883AA08063: ATOMO Disposable Impression Trays, Small Lower
• D883AA08053: ATOMO Disposable Impression Trays, Small Upper
• D883AA08043: ATOMO Disposable Impression Trays, Medium Lower
• D883AA08033: ATOMO Disposable Impression Trays, Medium Upper
• D883AA08023: ATOMO Disposable Impression Trays, Large Lower
• D883AA08013: ATOMO Disposable Impression Trays, Large Upper