DuraHand DH-100

GUDID 00810045920993

DuraHand, Pedi

INSTRUMENT SPECIALISTS, INC.

Limb/torso/head restraint, reusable

• Primary Device ID: 00810045920993
• NIH Device Record Key: a1614e8b-8457-4571-b4dc-92459a6ff7ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DuraHand
• Version Model Number: DuraHand
• Catalog Number: DH-100
• Company DUNS: 041517095
• Company Name: INSTRUMENT SPECIALISTS, INC.
• 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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810045920993 [Primary]

FDA Product Code

• CCX: Support, Patient Position

Sterilization

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

[00810045920993]

Moist Heat or Steam Sterilization

[00810045920993]

Moist Heat or Steam Sterilization

[00810045920993]

Moist Heat or Steam Sterilization

[00810045920993]

Moist Heat or Steam Sterilization

[00810045920993]

Moist Heat or Steam Sterilization

[00810045920993]

Moist Heat or Steam Sterilization

[00810045920993]

Moist Heat or Steam Sterilization

[00810045920993]

Moist Heat or Steam Sterilization

[00810045920993]

Moist Heat or Steam Sterilization

[00810045920993]

Moist Heat or Steam Sterilization

[00810045920993]

Moist Heat or Steam Sterilization

[00810045920993]

Moist Heat or Steam Sterilization

[00810045920993]

Moist Heat or Steam Sterilization

[00810045920993]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-31
• Device Publish Date: 2020-07-23

On-Brand Devices [DuraHand]

• 00810045921082: DuraHand, Extra Large - Surgical Advantage
• 00810045921075: DuraHand, Extra Large - Medical Products Resource
• 00810045921068: DuraHand, Extra Large - Integra Life Sciences
• 00810045921051: DuraHand, Extra Large
• 00810045921044: DuraHand, Large - Surgical Advantage
• 00810045921037: DuraHand, Large - Medical Products Resource
• 00810045921020: DuraHand, Large - Integra Life Sciences
• 00810045921013: DuraHand, Large
• 00810045921006: DuraHand, Pedi - Medical Products Resource
• 00810045920993: DuraHand, Pedi