GuideBlade Sample Kit

GUDID 00848530100179

GuideBlade Sample Kit - 3/pack

SUNSET HEALTHCARE SOLUTIONS, INC.

Scalpel, single-use
Primary Device ID00848530100179
NIH Device Record Key7f0627fd-3ac3-476d-9015-6df0e2c3df77
Commercial Distribution StatusIn Commercial Distribution
Brand NameGuideBlade Sample Kit
Version Model NumberGDB001-KIT
Company DUNS141668116
Company NameSUNSET HEALTHCARE SOLUTIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848530100179 [Primary]

FDA Product Code

EMFKnife, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-17
Device Publish Date2025-12-09

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

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10848530094703 - Anesthesia2025-12-18 Sunset Intubating Stylet - 14Fr
00848530100162 - Disposable Wire-Guided Scapel for Central Venous Cannulation2025-12-17 Disposable Surgical Scalpel with Guide Channel and Retractable Safety Sheath: Sterile - 50/Pack
00848530100179 - GuideBlade Sample Kit2025-12-17GuideBlade Sample Kit - 3/pack
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10848530105362 - Sunset Coban Tape Roll 2025-12-17 Use for sensor life extension or sensor cord stability 1" x 177"
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