NZA023080

GUDID 00840085269660

NAVIGATED, CORTICAL, STYLET TIP, TAP, 8.0MM

HYHTE HOLDINGS, INC.

Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable

• Primary Device ID: 00840085269660
• NIH Device Record Key: 92ab0448-f97a-46fd-b860-b5e85d7e9e1f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: NZA023080
• Catalog Number: NZA023080
• Company DUNS: 073029645
• Company Name: HYHTE HOLDINGS, 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840085269660 [Primary]

FDA Product Code

• OWL: Peripheral Catheter Insertion Kit

Sterilization

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

[00840085269660]

Moist Heat or Steam Sterilization

[00840085269660]

Moist Heat or Steam Sterilization

[00840085269660]

Moist Heat or Steam Sterilization

[00840085269660]

Moist Heat or Steam Sterilization

[00840085269660]

Moist Heat or Steam Sterilization

[00840085269660]

Moist Heat or Steam Sterilization

[00840085269660]

Moist Heat or Steam Sterilization

[00840085269660]

Moist Heat or Steam Sterilization

[00840085269660]

Moist Heat or Steam Sterilization

[00840085269660]

Moist Heat or Steam Sterilization

[00840085269660]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-02
• Device Publish Date: 2024-04-24

Devices Manufactured by HYHTE HOLDINGS, INC.

• 00840085254413 - NA: 2024-05-07 POLYAXIAL, TULIP
• 00840085254420 - NA: 2024-05-07 POLYAXIAL, HIGH TOP, TULIP
• 00840085254437 - NA: 2024-05-07 POLYAXIAL, EXTENDED TAB, TULIP
• 00840085254444 - NA: 2024-05-07 FAVORED ANGLE M/L, TULIP
• 00840085254451 - NA: 2024-05-07 FAVORED ANGLE M/L, HIGH TOP, TULIP
• 00840085254468 - NA: 2024-05-07 FAVORED ANGLE M/L, EXTENED TAB, TULIP
• 00840085254475 - NA: 2024-05-07 FAVORED ANGLE C/C, TULIP
• 00840085254482 - NA: 2024-05-07 FAVORED ANGLE C/C, HIGH TOP, TULIP