FDA.reportPublic FDA data

SunMed

Primary DI
10889483159019
Brand
SunMed
Company
SUNMED, LLC
Model
5-5338-09
Catalog number
5-5338-09
Device description
Sunmed Disposable Layrngscope handle, medium, 20/bx, sterile
Published
2023-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCWLARYNGOSCOPE, RIGID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889483159019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088948315901910889483159019

GMDN Terms#

Term, Definition table
TermDefinition
Laryngoscope handle, single-useA clean, non-sterile, hand-held segment of a laryngoscope (i.e., non-endoscopic rigid type) designed to manipulate the laryngoscope blade during airway access and intubation. It is a cylindrical device that contains batteries/light-emitting cells to provide the energy/light for the airway-illuminating feature of the laryngoscope (e.g., small light bulb, fibreoptics), and can accommodate various blades. It is available in various sizes and may be magnetic resonance imaging (MRI) compatible. This is a single-use device; the batteries/light-emitting cells are intended to be removed for reuse before the device is discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)433-2797info@sun-med.com

Regulatory Flags#

DUNS number
069009268
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889483479407Atellica® VTR Syringes115613422023-06-30
10889483479414Atellica® VTR Syringes115613432023-06-30
10889483479469Atellica® VTR Syringes115613482023-06-30
10889483054321AirLife™048004802025-12-18
10889483054338AirLife™079507952025-12-19
10889483229422AirLife™048504852025-12-19
10889483564288BALLARD™22103-522103-52025-11-20
10889483564394BALLARD™22113-522113-52025-11-21
10889483564608BALLARD™227101322710132025-11-24
10889483564646BALLARD™22712183227121832025-11-24
10889483564806BALLARD™2271603-52271603-52025-11-21
10889483564813BALLARD™22716036-522716036-52025-11-21
10889483564905BALLARD™227166-5227166-52025-11-21
10889483564936BALLARD™2276-52276-52025-11-21
10889483567005BALLARD™2271652271652025-11-24
10889483623411BALLARD™22056-522056-52025-11-20
10889483623541BALLARD™2271516-52271516-52025-11-21
10889483562611BALLARD™227-5227-52025-11-21
10889483564370BALLARD™22108-522108-52025-11-21
10889483564424BALLARD™2255-52255-52025-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810071638688CuraplexBOUND TREE MEDICAL, LLCCCW2026-10-21
15056094505435PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
15056094505480PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
15056094505497PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505319PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505326PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505333PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505340PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505357PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505364PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505371PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505395PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505401PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505418PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505425PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505456PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505463PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505470PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
00190776434038MillenniumAvalign Technologies, Inc.CCW2026-10-09
00190776434045MillenniumAvalign Technologies, Inc.CCW2026-10-09
00190776434052MillenniumAvalign Technologies, Inc.CCW2026-10-09
06971834830016Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830023Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830030Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830047Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830542Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830559Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830566Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830573Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830580Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30