AESCULAP US414SU

GUDID 04046955285242

GOLDTIP IRRIG DISPO FCPS 190MM 0.5MM

AESCULAP, INC.

Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

• Primary Device ID: 04046955285242
• NIH Device Record Key: 3a13e5c4-1025-4674-b774-061f605f1446
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AESCULAP
• Version Model Number: US414SU
• Catalog Number: US414SU
• Company DUNS: 082594540
• Company Name: AESCULAP, INC.
• Device Count: 5
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(800)282-9000
• Email: GUDID.BBMUS_Service@bbraun.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046955285242 [Unit of Use]
GS1	04046955285259 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K900533

FDA Product Code

• GEI: Electrosurgical, cutting & coagulation & accessories

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: 2020-08-18
• Device Publish Date: 2020-08-10

On-Brand Devices [AESCULAP]

• 05055049007423: STEAM STER LOCKS ORANGE
• 05055049000608: ETO STERILIZATION LOCKS GREEN
• 14522281506826: Indicator Label
• 14522281506819: Disposable Filter, Reusable Filter
• 14522281000508: PROCESS INDICATOR CARD SCORED
• 04046964161629: CUSHING ROSE GOLD Bipolar Forceps, straight, 7 1/2", (190 mm), working length: 3 1/2", (90 mm),
• 04046964909924: CUSTOM AESCULAP "PROCESSED" CARD
• 04046955211494: , non-sterile, reusable
• 04046955210831: , non-sterile, reusable
• 04046964169601: CUSHING ROSE GOLD Bipolar Forceps, straight, 7 1/2", (190 mm), working length: 3 1/2", (90 mm),
• 04046964161919: CUSHING ROSE GOLD Bipolar Forceps, straight, 7 1/2", (190 mm), working length: 3 1/2", (90 mm),
• 04046964161841: CUSHING ROSE GOLD Bipolar Forceps, straight, 7 1/2", (190 mm), working length: 3 1/2", (90 mm),
• 04046964161834: CUSHING ROSE GOLD Bipolar Forceps, straight, 7 1/2", (190 mm), working length: 3 1/2", (90 mm),
• 04046964161728: CUSHING ROSE GOLD Bipolar Forceps, straight, 7 1/2", (190 mm), working length: 3 1/2", (90 mm),
• 04046964161711: CUSHING ROSE GOLD Bipolar Forceps, straight, 7 1/2", (190 mm), working length: 3 1/2", (90 mm),
• 04046964161704: CUSHING ROSE GOLD Bipolar Forceps, straight, 7 1/2", (190 mm), working length: 3 1/2", (90 mm),
• 04046964582189: Forceps, 8 3/4", (222 mm), working length: 3 3/4", width: 0,50 mm
• 04046964581762: Forceps, 6 1/4", (159 mm), working length: 2 3/8", (60 mm), width: 0,50 mm
• 04046964958113: INVENTORY CARD
• 04046964790140: BIPOLAR FORCEP TRAY BTTM F 1/2SZ CONTAIN
• 04046964790133: BIPOLAR FORCEPS TRAY LID F 1/2SZ CONTAIN
• 04046964790126: BIPOLAR FORCEPS TRAY F 1/2SZ CONTAINER
• 04046964790119: CURETTE 230MM TRAY BOTTM F 1/2SZ CONTAIN
• 04046964790102: CURETTE 230MM TRAY LID F 1/2SZ CONTAIN
• 04046964790096: CURETTE 230MM TRAY FOR1/2SIZE CONTAINER
• 04046964790089: OSTEOTOME 230MM +MALLET TRAY BOTTOM1/2SZ
• 04046964790072: OSTEOTOME 230MM +MALLET TRAY LID 1/2SZ
• 04046964790065: OSTEOTOME 230MM + MALLET TRAY 1/2 SIZE
• 04046964790058: ENT BARRON SUCTION TRAY
• 04046964790041: ENT MICRO-SUCTION TRAY
• 04046964790034: ENT SPECULUM TRAY
• 04046964790027: ENT PICK AND HOOKE TRAY 10 INSTR
• 04046964790010: ENT ALLIGATOR TRAY
• 04046964708831: , non-sterile, reusable
• 04046964708824: , non-sterile, reusable
• 04046964589744: , non-sterile, reusable
• 04046964580017: MICRO PITUIT RNGR 2X6MM, DN, BLK, 180MM
• 04046964580000: Rongeur, downwards cutting, 6" (150 mm), 6 x 10 mm
• 04046964579998: Bone Rongeur, upwards cutting, 6" (150 mm), 6 x 10 mm
• 04046964579264: , non-sterile, reusable
• 04046964579226: COOLEY Atraumatic Vascular Clamp, Bulldog Clamp, curved, 4 3/4", (120 mm), serrated, non-sterile
• 04046964575433: RONGEUR DWN 5X10MM 304MM
• 04046964575426: RONGEUR UP 5X10MM 304MM
• 04046964575419: RONGEUR STR 5X10MM 304MM
• 04046964575402: RONGEUR DWN 5X10MM 280MM
• 04046964575396: RONGEUR UP 5X10MM 280MM
• 04046964575389: RONGEUR STR 5X10MM 280MM
• 04046964575372: RONGEUR DWN 5X10MM 228MM
• 04046964575365: RONGEUR UP 5X10MM 228MM
• 04046964575358: RONGEUR STR 5X10MM 228MM