FDA.reportPublic FDA data

IntuBrite Sterile

Primary DI
00607411966392
Brand
IntuBrite Sterile
Company
SALTER LABS
Model
S01-6017.C
Catalog number
S01-6017.C
Device description
STUBBY SINGLE USE DISPOSABLE FIBER OPTIC LARYNGOSCOPE HANDLE-STERILE
Published
2018-12-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
10607411966399PackageGS110In Commercial Distribution
00607411966392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060741196639910607411966399
00607411966392006074119663926074119663920607411966392

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.

Contacts#

Phone, Email table
PhoneEmail
+8004210024customercare@salterlabs.com

Regulatory Flags#

DUNS number
022721133
Device count
1
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
00607411102066N/A7925-257925-252016-09-24
00607411102080N/A7907-77907-72016-09-24
00607411102738N/A7914-147914-142016-12-22
00607411201547N/A9016SO-16542016-09-24
00607411700088N/A7907TLC-77907TLC-72016-10-10
00607411893483N/A7914TLC-147914TLC-142016-09-24
00607411966378IntuBrite SterileS01-6015.CS01-6015.C2018-12-13
00607411966385IntuBrite SterileS01-6016.CS01-6016.C2018-12-13
00607411973055AirLifeSO-2169-0SO-2169-02026-05-11
00607411973062AirLifeSO-2170-0SO-2170-02026-05-11
10607411007344Sticky WhiskersSW102-0-25SW102-0-252016-09-24
00607411200915N/AL7600-0L7600-02016-09-24
00607411300738AirLifeSO-1500-0SO-1500-02016-11-30
00607411889097AirLifeSO-1188-0SO-1188-02016-11-30
00607411889103AirLifeSO-1189-0SO-1189-02016-11-30
00607411889110AirLifeSO-1190-0SO-1190-02016-11-30
00607411918025AirLifeSO-1968-0SO-1968-02016-11-30
00607411918070AirLifeSO-1972-0SO-1972-02016-11-30
00607411102035Salter Labs8107V-02026-04-24
00607411800870N/A1107-01107-02016-11-30

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