OptaBlate 9700-811-000

GUDID 37613327591553

11G HAND DRILL PACK

STRYKER CORPORATION

Manual surgical rotary handpiece, single-use Manual surgical rotary handpiece, single-use Manual surgical rotary handpiece, single-use Manual surgical rotary handpiece, single-use Manual surgical rotary handpiece, single-use Manual surgical rotary handpiece, single-use Manual surgical rotary handpiece, single-use Manual surgical rotary handpiece, single-use Manual surgical rotary handpiece, single-use Manual surgical rotary handpiece, single-use

• Primary Device ID: 37613327591553
• NIH Device Record Key: 8869fdec-e9d5-4919-b5ce-2107c8737dc9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptaBlate
• Version Model Number: 9700811000
• Catalog Number: 9700-811-000
• Company DUNS: 196548481
• Company Name: STRYKER CORPORATION
• 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: true
• 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	07613327591552 [Primary]
GS1	37613327591553 [Package]; Contains: 07613327591552; Package: pack [6 Units]; In Commercial Distribution
GS1	57613327591557 [Package]; Package: case [10 Units]; In Commercial Distribution

FDA Product Code

• OCJ: spinal channeling instrument, vertebroplasty

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-14
• Device Publish Date: 2022-11-04

On-Brand Devices [OptaBlate]

• 07613327547610: RF GENERATOR
• 07613327524505: 150MM Temperature Sensor
• 07613327524482: 20 mm Probe Single Kit
• 07613327524475: 15MM Probe Single Kit
• 07613327524512: 15 mm Probe Dual Kit
• 07613327524499: 20 mm Probe Dual Kit
• 37613327591553: 11G HAND DRILL PACK