Truliant SPI-036634-15

GUDID 10885862593283

TRLNT FFG W SIDE POSTRIOR CPTURES, SZ 1.5

Exactech, Inc.

Osteotomy guide, reusable

• Primary Device ID: 10885862593283
• NIH Device Record Key: 9a0b832b-ea04-4804-80f0-4afc89b6edeb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Truliant
• Version Model Number: SPI-036634-15
• Catalog Number: SPI-036634-15
• Company DUNS: 157565946
• Company Name: Exactech, Inc.
• 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: false
• Expiration Date: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	10885862593283 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033883

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

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

[10885862593283]

Moist Heat or Steam Sterilization

[10885862593283]

Moist Heat or Steam Sterilization

[10885862593283]

Moist Heat or Steam Sterilization

[10885862593283]

Moist Heat or Steam Sterilization

[10885862593283]

Moist Heat or Steam Sterilization

[10885862593283]

Moist Heat or Steam Sterilization

[10885862593283]

Moist Heat or Steam Sterilization

[10885862593283]

Moist Heat or Steam Sterilization

[10885862593283]

Moist Heat or Steam Sterilization

[10885862593283]

Moist Heat or Steam Sterilization

[10885862593283]

Moist Heat or Steam Sterilization

[10885862593283]

Moist Heat or Steam Sterilization

[10885862593283]

Moist Heat or Steam Sterilization

[10885862593283]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-26
• Device Publish Date: 2022-08-18

On-Brand Devices [Truliant]

• 10885862320704: 02-020-13-0315
• 10885862320698: 02-020-13-0310
• 10885862320681: 02-020-13-0300
• 10885862320674: 02-020-13-0260
• 10885862320667: 02-020-13-0250
• 10885862320650: 02-020-13-0245
• 10885862320643: 02-020-13-0240
• 10885862315311: 02-020-13-0325
• 10885862315304: 02-020-13-0320
• 10885862314727: 02-020-13-0360
• 10885862314710: 02-020-13-0350
• 10885862314703: 02-020-13-0345
• 10885862314697: 02-020-13-0340
• 10885862314680: 02-020-13-0335
• 10885862314673: 02-020-13-0330
• 10885862314666: 02-020-13-0235
• 10885862314659: 02-020-13-0230
• 10885862314642: 02-020-13-0225
• 10885862314635: 02-020-13-0220
• 10885862314628: 02-020-13-0215
• 10885862314611: 02-020-13-0210
• 10885862314604: 02-020-13-0200
• 10885862314598: 02-020-11-0360
• 10885862314581: 02-020-11-0350
• 10885862314574: 02-020-11-0345
• 10885862314567: 02-020-11-0340
• 10885862314550: 02-020-11-0335
• 10885862314543: 02-020-11-0330
• 10885862314536: 02-020-11-0325
• 10885862314529: 02-020-11-0320
• 10885862314512: 02-020-11-0315
• 10885862314505: 02-020-11-0310
• 10885862314499: 02-020-11-0300
• 10885862314482: 02-020-11-0260
• 10885862314475: 02-020-11-0250
• 10885862314468: 02-020-11-0245
• 10885862314451: 02-020-11-0240
• 10885862314444: 02-020-11-0235
• 10885862314437: 02-020-11-0230
• 10885862314420: 02-020-11-0225
• 10885862314413: 02-020-11-0220
• 10885862314406: 02-020-11-0215
• 10885862314390: 02-020-11-0210
• 10885862314383: 02-020-11-0200
• 10885862306241: 02-022-45-4535
• 10885862305923: 02-022-45-4555
• 10885862305916: 02-022-45-4545
• 10885862512710: 02-012-63-2016
• 10885862512703: 02-012-63-2012
• 10885862512697: 02-012-63-2080