SABER 48002020X

GUDID 20705032069219

SABER 2MM20CM 150

CORDIS CORPORATION

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 20705032069219
• NIH Device Record Key: b93609c9-a51e-497d-8d5b-9bf2aca52b1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SABER
• Version Model Number: 48002020X
• Catalog Number: 48002020X
• Company DUNS: 806136177
• Company Name: CORDIS CORPORATION
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Upper limit of temperature 54 degrees C (130 F)
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Upper limit of temperature 54 degrees C (130 F)
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	20705032069219 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133843

FDA Product Code

• LIT: Catheter, angioplasty, peripheral, transluminal

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: 2016-08-01

On-Brand Devices [SABER]

• 20705032069929: SABER 2MM8CM 150
• 20705032069912: SABER 2MM6CM 150
• 20705032069905: SABER 2MM3CM 150
• 20705032069899: SABER 2MM4CM 150
• 20705032069882: SABER 5MM2CM 90
• 20705032069875: SABER 4MM8CM 90
• 20705032069868: SABER 4MM6CM 90
• 20705032069851: SABER 4MM4CM 90
• 20705032069844: SABER 4MM3CM 90
• 20705032069837: SABER 4MM30CM 90
• 20705032069820: SABER 4MM2CM 90
• 20705032069813: SABER 4MM25CM 90
• 20705032069806: SABER 4MM20CM 90
• 20705032069790: SABER 4MM15CM 90
• 20705032069783: SABER 4MM10CM 90
• 20705032069776: SABER 2MM3CM 90
• 20705032069769: SABER 2MM2CM 90
• 20705032069752: SABER 8MM3CM 150
• 20705032069745: SABER 8MM10CM 150
• 20705032069738: SABER 8MM6CM 150
• 20705032069721: SABER 8MM4CM 150
• 20705032069714: SABER 8MM2CM 150
• 20705032069707: SABER 7MM10CM 150
• 20705032069691: SABER 7MM8CM 150
• 20705032069684: SABER 7MM6CM 150
• 20705032069677: SABER 7MM4CM 150
• 20705032069660: SABER 7MM3CM 150
• 20705032069653: SABER 7MM2CM 150
• 20705032069646: SABER 6MM25CM 150
• 20705032069639: SABER 6MM20CM 150
• 20705032069622: SABER 6MM15CM 150
• 20705032069615: SABER 6MM10CM 150
• 20705032069608: 48006008X
• 20705032069592: SABER 6MM6CM 150
• 20705032069585: SABER 5MM8CM 150
• 20705032069578: SABER 5MM30CM 150
• 20705032069561: SABER 5MM25CM 150
• 20705032069554: SABER 5MM20CM 150
• 20705032069547: SABER 2.5MM2CM 150
• 20705032069530: SABER 5MM4CM 150
• 20705032069523: SABER 5MM3CM 150
• 20705032069516: SABER 5MM2CM 150
• 20705032069509: SABER 4MM30CM 150
• 20705032069493: SABER 4MM20CM 150
• 20705032069486: SABER 4MM15CM 150
• 20705032069479: SABER 4MM10CM 150
• 20705032069462: SABER 4MM8CM 150
• 20705032069455: SABER 4MM6CM 150
• 20705032069448: SABER 4MM4CM 150
• 20705032069431: SABER 4MM3CM 150