FDA.report

RUSCH

Primary DI
34026704626114
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN008273
Catalog number
88800
Device description
RUSCH DISPOGRIP SU STD HANDLE
Published
2018-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
CCWLARYNGOSCOPE, RIGID

Product Code Classifications

CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34026704626114PackageGS120In Commercial Distribution
44026704626111PackageGS110In Commercial Distribution
14026704626110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3402670462611434026704626114
4402670462611144026704626111
1402670462611014026704626110

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00COOL, DRY CONDITIONS

Sterilization Methods

Method

Contacts

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

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