DORO® Blade

GUDID 00425043553205

DORO® Blade Set 152 mm, Black Coated, 5 pcs consisting of: 3116-112 3116-122 3116-132 3116-142 3116-152

pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung

Surgical retractor/retraction system blade, reusable

• Primary Device ID: 00425043553205
• NIH Device Record Key: 342de5ba-05ae-4710-a1b8-ec3caaf3508b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DORO® Blade
• Version Model Number: 3116-102
• Company DUNS: 313517922
• Company Name: pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00425043553205 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001808

FDA Product Code

• HBL: Holder, Head, Neurosurgical (Skull Clamp)

Sterilization

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

[00425043553205]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-30

On-Brand Devices [DORO® Blade]

• 00425043553205: DORO® Blade Set 152 mm, Black Coated, 5 pcs consisting of:
• 04250435532058: DORO® Blade Set 152 mm, Black Coated, 5 pcs consisting of:
• 04250435532041: DORO® Blade Set 102 mm, Black Coated, 5 pcs consisting of:
• 04250435532034: DORO® Blade 152x13mm
• 04250435532027: DORO® Blade 152x26mm
• 04250435532010: DORO® Blade 152x20mm
• 04250435532003: DORO® Blade 152x16mm
• 04250435531990: DORO® Blade 152x10mm
• 04250435531983: DORO® Blade 152x7mm
• 04250435531976: DORO® Blade 102x7mm
• 04250435531969: DORO® Blade 102x10mm
• 04250435531952: DORO® Blade 102x16mm
• 04250435531945: DORO® Blade 102x20mm
• 04250435531938: DORO® Blade 102x13mm
• 04250435531921: DORO® Blade 102x26mm
• 04250435503591: DORO® Blade, Rounded Tip, Black Coated, 102 x 26 mm
• 04250435503584: DORO® Blade, Rounded Tip, Black Coated, 102 x 20 mm
• 04250435503577: DORO® Blade, Rounded Tip, Black Coated 102 x 16 mm
• 04250435503560: DORO® Blade, Rounded Tip, Black Coated, 102 x 10 mm
• 04250435503553: DORO® Blade, Rounded Tip, Black Coated, 102 x 7 mm
• 04250435503546: DORO® Blade Set 102 mm, Rounded Tip, Black Coated, 5 pcs consisting of:
• 04250435503539: DORO® Blade, Conical, Black Coated, 102 x 6 mm
• 04250435503522: DORO® Blade, Conical, Black Coated, 152 x 6 mm
• 04250435503515: DORO® Blade, Conical, Black Coated, 102 x 5 mm
• 04250435503508: DORO® Blade, Conical, Black Coated, 152 x 5 mm
• 04250435503492: DORO® Blade, Conical, Black Coated, 102 x 4 mm
• 04250435503485: DORO® Blade, Conical, Black Coated, 102 x 4 mm
• 04250435503478: DORO® Blade, Conical, Black Coated, 102 x 3 mm
• 04250435503461: DORO® Blade, Conical, Black Coated, 152 x 3 mm
• 04250435503454: DORO® Blade, Conical, Black Coated, 102 x 2 mm
• 04250435503447: DORO® Blade, Conical, Black Coated, 152 x 2 mm
• 04250435503430: DORO® Blade Set 102 mm, Conical, Black Coated, 5 pcs consisting of:
• 04250435503423: DORO® Blade Set 152 mm, Conical, Black Coated, 5 pcs consisting of:
• 04250435503157: DORO® Blade, Black Coated, 102 x 13 mm
• 04250435503140: DORO® Blade, Black Coated, 152 x 13 mm
• 04250435503133: DORO® Blade, Black Coated, 102 x 26 mm
• 04250435503126: DORO® Blade, Black Coated, 152 x 26 mm
• 04250435503119: DORO® Blade, Black Coated, 102 x 20 mm
• 04250435503102: DORO® Blade, Black Coated, 152 x 20 mm
• 04250435503096: DORO® Blade, Black Coated, 102 x 16 mm
• 04250435503089: DORO® Blade, Black Coated, 152 x 16 mm
• 04250435503072: DORO® Blade, Black Coated, 102 x 10 mm
• 04250435503065: DORO® Blade, Black Coated, 152 x 10 mm
• 04250435503058: DORO® Blade, Black Coated, 102 x 7mm
• 04250435503041: DORO® Blade, Black Coated, 152 x 7 mm
• 04250435503034: DORO® Blade Set 102 mm, Black Coated, 5 pcs consisting of:
• 04250435503027: DORO® Blade Set 152 mm, Black Coated, 5 pcs consisting of: