MATISSE

GUDID 00841732135789

CTL MEDICAL CORPORATION

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00841732135789
• NIH Device Record Key: c22b8779-e231-46ae-b280-8fa55c663bb4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MATISSE
• Version Model Number: 013.1308
• Company DUNS: 080138504
• Company Name: CTL MEDICAL 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: 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	00841732135789 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132365

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00841732135789]

Moist Heat or Steam Sterilization

[00841732135789]

Moist Heat or Steam Sterilization

[00841732135789]

Moist Heat or Steam Sterilization

[00841732135789]

Moist Heat or Steam Sterilization

[00841732135789]

Moist Heat or Steam Sterilization

[00841732135789]

Moist Heat or Steam Sterilization

[00841732135789]

Moist Heat or Steam Sterilization

[00841732135789]

Moist Heat or Steam Sterilization

[00841732135789]

Moist Heat or Steam Sterilization

[00841732135789]

Moist Heat or Steam Sterilization

[00841732135789]

Moist Heat or Steam Sterilization

[00841732135789]

Moist Heat or Steam Sterilization

[00841732135789]

Moist Heat or Steam Sterilization

[00841732135789]

Moist Heat or Steam Sterilization

[00841732135789]

Moist Heat or Steam Sterilization

[00841732135789]

Moist Heat or Steam Sterilization

[00841732135789]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-29
• Device Publish Date: 2023-03-21

On-Brand Devices [MATISSE]

• 00841732121195: 013.7562
• 00841732121188: 013.7561
• 00841732121171: 013.7552
• 00841732121164: 013.7551
• 00841732121058: 013.1210
• 00841732121041: 013.1209
• 00841732121034: 013.1208
• 00841732121027: 013.1207
• 00841732121010: 013.1206
• 00841732121003: 013.1205
• 00841732120877: 013.0610
• 00841732120860: 013.0609
• 00841732120853: 013.0608
• 00841732120846: 013.0607
• 00841732120839: 013.0606
• 00841732120822: 013.0605
• 00841732120815: 013.0410
• 00841732120808: 013.0409
• 00841732120792: 013.0408
• 00841732120785: 013.0407
• 00841732120778: 013.0406
• 00841732120761: 013.0405
• 00841732120754: 013.0210
• 00841732120747: 013.0209
• 00841732120730: 013.0208
• 00841732120723: 013.0207
• 00841732120716: 013.0206
• 00841732120709: 013.0205
• 00841732138032: 013.4412
• 00841732138025: 013.4411
• 00841732138018: 013.4222B
• 00841732138001: 013.4221B
• 00841732137998: 013.4220B
• 00841732137981: 013.4219B
• 00841732137974: 013.4218B
• 00841732137967: 013.4217B
• 00841732137950: 013.4216B
• 00841732137943: 013.4215B
• 00841732137936: 013.4212B
• 00841732137912: 013.4210B
• 00841732137905: 013.4209B
• 00841732137899: 013.4208B
• 00841732137882: 013.4207B
• 00841732137875: 013.4206B
• 00841732137868: 013.4205B
• 00841732137844: 013.4201B
• 00841732137837: 013.4200B
• 00841732137820: 013.4199B
• 00841732137813: 013.4198B
• 00841732137806: 013.4197B