Trulife

GUDID 00645517327983

PED HIP ABDUCT ORTHOSIS SM

TRULIFE LIMITED

Infant hip harness

• Primary Device ID: 00645517327983
• NIH Device Record Key: 00a5a817-7300-4d70-9cca-e6a16440c515
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trulife
• Version Model Number: 015COH1
• Company DUNS: 289728891
• Company Name: TRULIFE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00645517327983 [Primary]

FDA Product Code

• IOZ: SPLINT, ABDUCTION, CONGENITAL HIP DISLOCATION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-06-07
• Device Publish Date: 2022-12-31

On-Brand Devices [Trulife]

• 00645517894843: Foot Kinetic Light, No Pylon RT 30 #5 DK BRN
• 00645517894836: Foot Kinetic Light, No Pylon RT 30 #4 DK BRN
• 00645517894829: Foot Kinetic Light, No Pylon LFT 30 #5 DK BRN
• 00645517894812: Foot Kinetic Light, No Pylon LFT 30 #4 DK BRN
• 00645517894805: Foot Kinetic Light, No Pylon RT 29 #5 DK BRN
• 00645517894799: Foot Kinetic Light, No Pylon RT 29 #4 DK BRN
• 00645517894782: Foot Kinetic Light, No Pylon RT 29 #3 DK BRN
• 00645517894775: Foot Kinetic Light, No Pylon LFT 29 #5 DK BRN
• 00645517894768: Foot Kinetic Light, No Pylon LFT 29 #4 DK BRN
• 00645517894751: Foot Kinetic Light, No Pylon LFT 29 #3 DK BRN
• 00645517894744: Foot Kinetic Light, No Pylon RT 28 #5 DK BRN
• 00645517894737: Foot Kinetic Light, No Pylon RT 28 #4 DK BRN
• 00645517894720: Foot Kinetic Light, No Pylon RT 28 #3 DK BRN
• 00645517894713: Foot Kinetic Light, No Pylon RT 28 #2 DK BRN
• 00645517894706: Foot Kinetic Light, No Pylon LFT 28 #5 DK BRN
• 00645517894690: Foot Kinetic Light, No Pylon LFT 28 #4 DK BRN
• 00645517894683: Foot Kinetic Light, No Pylon LFT 28 #3 DK BRN
• 00645517894676: Foot Kinetic Light, No Pylon LFT 28 #2 DK BRN
• 00645517894669: Foot Kinetic Light, No Pylon RT 27 #5 DK BRN
• 00645517894652: Foot Kinetic Light, No Pylon RT 27 #4 DK BRN
• 00645517894645: Foot Kinetic Light, No Pylon RT 27 #3 DK BRN
• 00645517894638: Foot Kinetic Light, No Pylon RT 27 #2 DK BRN
• 00645517894621: Foot Kinetic Light, No Pylon LFT 27 #5 DK BRN
• 00645517894614: Foot Kinetic Light, No Pylon LFT 27 #4 DK BRN
• 00645517894607: Foot Kinetic Light, No Pylon LFT 27 #3 DK BRN
• 00645517894591: Foot Kinetic Light, No Pylon LFT 27 #2 DK BRN
• 00645517894584: Foot Kinetic Light, No Pylon RT 26 #5 DK BRN
• 00645517894577: Foot Kinetic Light, No Pylon RT 26 #4 DK BRN
• 00645517894560: Foot Kinetic Light, No Pylon RT 26 #3 DK BRN
• 00645517894553: Foot Kinetic Light, No Pylon RT 26 #2 DK BRN
• 00645517894546: Foot Kinetic Light, No Pylon LFT 26 #5 DK BRN
• 00645517894539: Foot Kinetic Light, No Pylon LFT 26 #4 DK BRN
• 00645517894522: Foot Kinetic Light, No Pylon LFT 26 #3 DK BRN
• 00645517894515: Foot Kinetic Light, No Pylon LFT 26 #2 DK BRN
• 00645517894508: Foot Kinetic Light, No Pylon RT 25 #4 DK BRN
• 00645517894492: Foot Kinetic Light, No Pylon RT 25 #3 DK BRN
• 00645517894485: Foot Kinetic Light, No Pylon RT 25 #2 DK BRN
• 00645517894478: Foot Kinetic Light, No Pylon LFT 25 #4 DK BRN
• 00645517894461: Foot Kinetic Light, No Pylon LFT 25 #3 DK BRN
• 00645517894454: Foot Kinetic Light, No Pylon LFT 25 #2 DK BRN
• 00645517894447: Foot Kinetic Light, No Pylon RT 24 #4 DK BRN
• 00645517894430: Foot Kinetic Light, No Pylon RT 24 #3 DK BRN
• 00645517894423: Foot Kinetic Light, No Pylon RT 24 #2 DK BRN
• 00645517894416: Foot Kinetic Light, No Pylon LFT 24 #4 DK BRN
• 00645517894409: Foot Kinetic Light, No Pylon LFT 24 #3 DK BRN
• 00645517894393: Foot Kinetic Light, No Pylon LFT 24 #2 DK BRN
• 00645517894386: Foot Kinetic Light, No Pylon RT 23 #2 DK BRN
• 00645517894379: Foot Kinetic Light, No Pylon RT 23 #1 DK BRN
• 00645517894362: Foot Kinetic Light, No Pylon LFT 23 #2 DK BRN
• 00645517894355: Foot Kinetic Light, No Pylon LFT 23 #1 DK BRN