FDA.reportPublic FDA data

RUSCH

Primary DI
34026741626092
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN048388
Catalog number
004551035
Device description
RUSCH GREENLITE SU MTL BLADE MAC 3.5
Published
2018-09-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
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
34026741626092PackageGS120Not in Commercial Distribution
44026742626098PackageGS110Not in Commercial Distribution
14026740626099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3402674162609234026741626092
4402674262609844026742626098
1402674062609914026740626099

GMDN Terms#

Term, Definition table
TermDefinition
Laryngoscope blade, single-useThe segment of a laryngoscope (i.e., rigid intubation type) intended to be inserted into the oral cavity to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It is connected to the laryngoscope handle and illumination of the airway is provided by a small built-in light bulb or a fibreoptic light. This device may be curved or straight and of various designs and lengths; it may be hinged/interchanged with the handle. Some types are magnetic resonance imaging (MRI) compatible. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00COOL, DRY CONDITIONS

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506089633ELMED INCORPORATEDELMED INCORPORATEDCCW2026-03-17
06974525071507Video LaryngoscopeShenzhen Zhixin Biomedical Technology Co., Ltd.CCW2026-02-04
00198506088063ELMED INCORPORATEDELMED INCORPORATEDCCW2026-01-22
00198506087868ELMED INCORPORATEDELMED INCORPORATEDCCW2026-01-15
00198506087875ELMED INCORPORATEDELMED INCORPORATEDCCW2026-01-15
00198506087882ELMED INCORPORATEDELMED INCORPORATEDCCW2026-01-15
00198506087905ELMED INCORPORATEDELMED INCORPORATEDCCW2026-01-15
05707480164264Ambu® SureSight® Data CableAmbu A/SCCW2025-12-19
05707480164301Ambu® SureSight® Battery ChargerAmbu A/SCCW2025-12-19
09348811110183INKAThe Trustee for KAISER FAMILY TRUSTCCW2025-11-25
10884521849761McGRATH MAC+Covidien LPCCW2025-11-17
00198506085727ELMED INCORPORATEDELMED INCORPORATEDCCW2025-09-19
04250676716095Surgical laryngoscopeSpiggle & Theis Medizintechnik GmbHCCW2025-09-19
04250381858431Laser laryngoscope, size 1, blackSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250381858448Laser laryngoscope, size 2, blackSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250381858455Laser laryngoscope, size 3, blackSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250381858462Laser laryngoscope, size 4, blackSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250381858479Laser laryngoscope, size 5, blackSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250381858486Laser laryngoscope, size 6, black, forSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250381858493Laser laryngoscope, size 7, blackSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250676739933Holinger laryngoscopeSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250676741646Laser laryngoscope, Ulm typeSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250676741660Smoke evacuation tubeSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
00840183530662BR Surgical, LLCBR Surgical, LLCCCW2025-08-21
20197344135667MEDLINEMEDLINE INDUSTRIES, INC.CCW2025-08-14
20197344135834MEDLINEMEDLINE INDUSTRIES, INC.CCW2025-08-14
20197344135919MEDLINEMEDLINE INDUSTRIES, INC.CCW2025-08-14
20197344135933MEDLINEMEDLINE INDUSTRIES, INC.CCW2025-08-14
20197344135964MEDLINEMEDLINE INDUSTRIES, INC.CCW2025-08-14
20197344135971MEDLINEMEDLINE INDUSTRIES, INC.CCW2025-08-14