DIMENSION

GUDID 00840606162029

DIMENSION® 180° RIGHT BLADE 18MM x 100MM

SPINAL ELEMENTS, INC.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00840606162029
• NIH Device Record Key: a184a555-47f1-472d-a0e2-ab2d901a9ac1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIMENSION
• Version Model Number: 11075-900
• Company DUNS: 610712213
• Company Name: SPINAL ELEMENTS, 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00840606162029 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00840606162029]

Moist Heat or Steam Sterilization

[00840606162029]

Moist Heat or Steam Sterilization

[00840606162029]

Moist Heat or Steam Sterilization

[00840606162029]

Moist Heat or Steam Sterilization

[00840606162029]

Moist Heat or Steam Sterilization

[00840606162029]

Moist Heat or Steam Sterilization

[00840606162029]

Moist Heat or Steam Sterilization

[00840606162029]

Moist Heat or Steam Sterilization

[00840606162029]

Moist Heat or Steam Sterilization

[00840606162029]

Moist Heat or Steam Sterilization

[00840606162029]

Moist Heat or Steam Sterilization

[00840606162029]

Moist Heat or Steam Sterilization

[00840606162029]

Moist Heat or Steam Sterilization

[00840606162029]

Moist Heat or Steam Sterilization

[00840606162029]

Moist Heat or Steam Sterilization

[00840606162029]

Moist Heat or Steam Sterilization

[00840606162029]

Moist Heat or Steam Sterilization

[00840606162029]

Moist Heat or Steam Sterilization

[00840606162029]

Moist Heat or Steam Sterilization

[00840606162029]

Moist Heat or Steam Sterilization

[00840606162029]

Moist Heat or Steam Sterilization

[00840606162029]

Moist Heat or Steam Sterilization

[00840606162029]

Moist Heat or Steam Sterilization

[00840606162029]

Moist Heat or Steam Sterilization

[00840606162029]

Moist Heat or Steam Sterilization

[00840606162029]

Moist Heat or Steam Sterilization

[00840606162029]

Moist Heat or Steam Sterilization

[00840606162029]

Moist Heat or Steam Sterilization

[00840606162029]

Moist Heat or Steam Sterilization

[00840606162029]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-12-10
• Device Publish Date: 2020-11-09

On-Brand Devices [DIMENSION]

• 00840606167178: Dimension® Split Tube Blade Set Tray Insert
• 00840606167161: Dimension® Split Tube Blade Set Tray Base
• 00840606167154: Dimension® Split Tube Blade Set Tray Lid
• 00840606167147: Dimension® Split Tube Blade Set Tray Assembly
• 00840606167291: DIMENSION® TLIF RETRACTOR DILATOR 1ST DILATOR
• 00840606167260: DIMENSION® TLIF RETRACTOR DILATOR 3RD DILATOR, 22MM
• 00840606167253: DIMENSION® TLIF RETRACTOR DILATOR 3RD DILATOR, 18MM
• 00840606167246: DIMENSION® TLIF RETRACTOR DILATOR 2ND DILATOR, 15MM
• 00840606167239: DIMENSION® TLIF RETRACTOR DILATOR 2ND DILATOR, 13MM
• 00840606162227: DIMENSION® 180° LEFT BLADE 18MM x 120MM
• 00840606162210: DIMENSION® 180° LEFT BLADE 18MM x 110MM
• 00840606162203: DIMENSION® 180° LEFT BLADE 18MM x 100MM
• 00840606162197: DIMENSION® 180° LEFT BLADE 18MM x 90MM
• 00840606162180: DIMENSION® 180° LEFT BLADE 18MM x 80MM
• 00840606162173: DIMENSION® 180° LEFT BLADE 18MM x 70MM
• 00840606162166: DIMENSION® 180° LEFT BLADE 18MM x 60MM
• 00840606162159: DIMENSION® 180° LEFT BLADE 18MM x 50MM
• 00840606162142: DIMENSION® 180° LEFT BLADE 18MM x 40MM
• 00840606162135: DIMENSION® 180° LEFT BLADE 22MM x 120MM
• 00840606162128: DIMENSION® 180° LEFT BLADE 22MM x 110MM
• 00840606162111: DIMENSION® 180° LEFT BLADE 22MM x 100MM
• 00840606162104: DIMENSION® 180° LEFT BLADE 22MM x 90MM
• 00840606162098: DIMENSION® 180° LEFT BLADE 22MM x 80MM
• 00840606162081: DIMENSION® 180° LEFT BLADE 22MM x 70MM
• 00840606162074: DIMENSION® 180° LEFT BLADE 22MM x 60MM
• 00840606162067: DIMENSION® 180° LEFT BLADE 22MM x 50MM
• 00840606162050: DIMENSION® 180° LEFT BLADE 22MM x 40MM
• 00840606162043: DIMENSION® 180° RIGHT BLADE 18MM x 120MM
• 00840606162036: DIMENSION® 180° RIGHT BLADE 18MM x 110MM
• 00840606162029: DIMENSION® 180° RIGHT BLADE 18MM x 100MM
• 00840606162012: DIMENSION® 180° RIGHT BLADE 18MM x 90MM
• 00840606162005: DIMENSION® 180° RIGHT BLADE 18MM x 80MM
• 00840606161992: DIMENSION® 180° RIGHT BLADE 18MM x 70MM
• 00840606161985: DIMENSION® 180° RIGHT BLADE 18MM x 60MM
• 00840606161978: DIMENSION® 180° RIGHT BLADE 18MM x 50MM
• 00840606161961: DIMENSION® 180° RIGHT BLADE 18MM x 40MM
• 00840606161954: DIMENSION® 180° RIGHT BLADE 22MM x 120MM
• 00840606161947: DIMENSION® 180° RIGHT BLADE 22MM x 110MM
• 00840606161930: DIMENSION® 180° RIGHT BLADE 22MM x 100MM
• 00840606161923: DIMENSION® 180° RIGHT BLADE 22MM x 90MM
• 00840606161916: DIMENSION® 180° RIGHT BLADE 22MM x 80MM
• 00840606161909: DIMENSION® 180° RIGHT BLADE 22MM x 70MM
• 00840606161893: DIMENSION® 180° RIGHT BLADE 22MM x 60MM
• 00840606161886: DIMENSION® 180° RIGHT BLADE 22MM x 50MM
• 00840606161879: DIMENSION® 180° RIGHT BLADE 22MM x 40MM