Stryker

GUDID 00843059116694

PHANTOM LIGHT SOURCE

TEDAN SURGICAL INNOVATIONS, L.L.C.

General-purpose light source

• Primary Device ID: 00843059116694
• NIH Device Record Key: f9328100-aaf8-4d8e-93ac-096f40c94238
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stryker
• Version Model Number: 48252106
• Company DUNS: 791619393
• Company Name: TEDAN SURGICAL INNOVATIONS, L.L.C.
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843059116694 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093792

FDA Product Code

• FCW: Light Source, Fiberoptic, Routine

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-15
• Device Publish Date: 2017-12-01

On-Brand Devices [Stryker]

• 00843059122916: LEAD, EXTENSION BLUE 183 CM / 72 IN
• 00843059122909: LEAD, CROCODILE CLIP, 122 CM / 48 IN
• 00843059122893: PHANTOM ML RETRACTOR BLADES (L&R), 22MM DIA. X 90MM, FUCHSIA
• 00843059122886: PHANTOM ML RETRACTOR BLADES (L&R), 22MM DIA. X 70MM, LIGHT GREEN
• 00843059122879: BAYONETED BALL PROBE, SHORT RIGHT
• 00843059122862: EPSTEIN CURETTE, BAYONET, UPBITING 7MM
• 00843059116700: PHANTOM ACCESSORY ARM 400MM L COLUMN - COMPLETE SET
• 00843059116694: PHANTOM LIGHT SOURCE
• 00843059105049: UNIVERSAL LIGHT CABLE KIT
• 00843059105032: Rongeur, Bayonet, Upbiting, 2MM x 10MM
• 00843059105025: Rongeur, Bayonet, 3MM x 10MM
• 00843059105018: Cup Curette, Bayonet, Reverse Angle, 7.5MM
• 00843059105001: Cup Curette, Bayonet, Forward Angle, 7.5MM
• 00843059104998: Cup Curette, Bayonet, Straight Cup, 7.5MM
• 00843059104981: Cup Curette, Bayonet, Reverse Angle, 4.4MM
• 00843059104974: Cup Curette, Bayonet, Forward Angle, 4.4MM
• 00843059104967: Cup Curette, Bayonet, Straight, 4.4MM
• 00843059104950: Micro Pituitary, Left Curve, 2MM x 6MM
• 00843059104943: Micro Scissor, Left Curve, 5MM
• 00843059104936: Penfield, CVD, Suction, Down
• 00843059104929: Penfield, CVD, Suction, Up
• 00843059104912: Penfield, CVD, Bayonet, Down
• 00843059104905: Penfield, CVD, Bayonet, Up
• 00843059104899: Penfield, Bayonet, Down Curve
• 00843059104882: Penfield, Bayonet, Up Curve
• 00843059104875: Dissector, Right Bayonet, 1MM, 8.5MM Offset
• 00843059104868: Dissector, Straight Bayonet, 1MM, 8.5MM Offset
• 00843059104851: Dissector, Left Bayonet, 1MM, 8.5MM Offset
• 00843059104844: Nerve Hook, Right Bayonet, 1MM, 2.5MM Offset
• 00843059104837: Nerve Hook, Straight Bayonet, 1MM, 2.5MM Offset
• 00843059104820: Nerve Hook, Left Bayonet, 1MM, 2.5MM Offset
• 00843059104813: Nerve Hook, Right Bayonet, 1MM, 4.5MM Offset
• 00843059104806: Nerve Hook, Straight Bayonet, 1MM, 4.5MM Offset
• 00843059104790: Nerve Hook, Left Bayonet, 1MM, 4.5MM Offset
• 00843059104783: Ball Probe, Right Bayonet, 2MM, 11MM Offset
• 00843059104776: Ball Probe, Straight Bayonet, 2MM, 11MM Offset
• 00843059104769: Ball Probe, Left Bayonet, 2MM, 11MM Offset
• 00843059104752: Ball Probe, Short, Left Bayonet, 2MM, 7MM Hook
• 00843059104745: #7 Penfield, Bayonet
• 00843059104738: #4 Penfield, Bayonet
• 00843059104721: #2 Penfield, Bayonet
• 00843059104714: Woodson Probe, Bayonet, 1.9MM
• 00843059104707: Cup Curette, Bayonet, Reverse Angle, 5.2MM
• 00843059104691: Cup Curette, Bayonet, Forward Angle, 5.2MM
• 00843059104684: Cup Curette, Bayonet, Straight, 5.2MM
• 00843059104677: Cup Curette, Bayonet, Reverse Angle, 3.6MM
• 00843059104660: Cup Curette, Bayonet, Forward Angle, 3.6MM
• 00843059104653: Cup Curette, Bayonet, Straight, 3.6MM
• 00843059104646: Micro Scissor, Curved, 2MM
• 00843059104639: Rongeur, Bayonet, Upbiting, 3MM x 10MM