Obturator

GUDID 04059082008790

SOPRO-COMEG GmbH

Rigid endoscope obturator

• Primary Device ID: 04059082008790
• NIH Device Record Key: 109b44a6-67f5-40ae-9700-1b7ed85e8805
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Obturator
• Version Model Number: 195 050 002BC
• Company DUNS: 507185952
• Company Name: SOPRO-COMEG GmbH
• 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: false
• 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
GS1	04059082008790 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971881

FDA Product Code

• FDC: RESECTOSCOPE, WORKING ELEMENT

Sterilization

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

[04059082008790]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-12

On-Brand Devices [Obturator]

• 04059082033303: 191 501 766
• 04059082033280: 191 501 756
• 04059082033211: 191 402 256
• 04059082033174: 191 401 805
• 04059082033167: 191 401 802
• 04059082033129: 191 401 797
• 04059082033044: 191 401 756
• 04059082032986: 191 271 756
• 04059082032948: 191 241 086
• 04059082032924: 191 240 986
• 04059082032887: 191 191 146
• 04059082032856: 191 191 046
• 04059082031835: 199 080 000
• 04059082031804: 199 075 010
• 04059082031798: 199 075 000
• 04059082031781: 199 070 000
• 04059082031774: 199 060 000
• 04059082031767: 199 050 002
• 04059082031637: 195 900 070
• 04059082031620: 195 810 112
• 04059082031590: 195 800 110
• 04059082031569: 195 400 050
• 04059082031460: 195 075 020
• 04059082031453: 195 075 010
• 04059082031446: 195 075 000
• 04059082031439: 195 060 000
• 04059082031422: 195 050 002
• 04059082029764: 195 110 060
• 04059082025421: 395 015 019
• 04059082010892: 199 080 000BC
• 04059082010861: 199 075 010BC
• 04059082010854: 199 075 000BC
• 04059082010847: 199 070 000BC
• 04059082010830: 199 060 000BC
• 04059082010823: 199 050 002BC
• 04059082009957: 195 900 070BC
• 04059082009834: 195 810 112BC
• 04059082009711: 195 800 110BC
• 04059082009551: 195 400 050BC
• 04059082009292: 195 110 060BC
• 04059082008899: 195 075 020BC
• 04059082008882: 195 075 010BC
• 04059082008868: 195 075 000BC
• 04059082008813: 195 060 000BC
• 04059082008790: 195 050 002BC
• 04059082007915: 191 501 766BC
• 04059082007892: 191 501 756BC
• 04059082007625: 191 402 256BC
• 04059082007434: 191 401 805BC
• 04059082007410: 191 401 803