Geistlich Bio-Gide® Shape

GUDID 07610221012220

Geistlich Pharma AG

Collagen dental regeneration membrane

• Primary Device ID: 07610221012220
• NIH Device Record Key: 14d1d263-2d08-420b-a25a-dd551a40249f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Geistlich Bio-Gide® Shape
• Version Model Number: 500377
• Company DUNS: 480781728
• Company Name: Geistlich Pharma AG
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• 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 Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07610221012220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171643

FDA Product Code

• NPL: Barrier, Animal Source, Intraoral

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: 2018-07-06
• Device Publish Date: 2017-12-15

Devices Manufactured by Geistlich Pharma AG

• 07610221015481 - Geistlich Fibro-Gide®: 2022-09-19
• 07610221015498 - Geistlich Fibro-Gide®: 2022-09-19
• 07610221071906 - Wound Matrix PLUS: 2022-09-19
• 07610221071913 - Wound Matrix PLUS: 2022-09-19
• 07610221014200 - Geistlich Nexo-Gide®: 2021-09-09
• 07610221014217 - Geistlich Nexo-Gide®: 2021-09-09
• 07610221014224 - Geistlich Nexo-Gide®: 2021-09-09
• 07610221015320 - Geistlich Bio-Oss®: 2021-06-23