FDA.reportPublic FDA data

Penlon

Primary DI
05051977003605
Brand
Penlon
Company
PENLON LTD
Model
408001002
Catalog number
408001002
Device description
HANDLE SHORT MRI
Published
2024-12-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
false

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
05051977003605PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051977003605050519770036055051977003605

GMDN Terms#

Term, Definition table
TermDefinition
Laryngoscope handle, reusableThe hand-held segment of a laryngoscope (i.e., non-endoscopic rigid type) used to manipulate the laryngoscope blade during airway access and intubation. It is a cylindrical device that contains the batteries/light-emitting cells that provide 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 reusable device.

Contacts#

Phone, Email table
PhoneEmail
800-328-6216customer.service@penlon.com

Regulatory Flags#

DUNS number
458942687
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
true
Expiration date on label
false
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
05051977003223Penlon4080010044080010042025-04-10
05051977003599Penlon4080010014080010012024-12-06
05051977003681Penlon4080010124080010122024-12-06
05051977003698Penlon4080010134080010132024-12-06
05051977003704Penlon4080010144080010142024-12-06
05051977003711Penlon4080010154080010152024-12-06
05051977003728Penlon4080010164080010162024-12-06
05051977003735Penlon4080010174080010172024-12-06
05051977003742Penlon4080010184080010182024-12-06
05051977003759Penlon4080010194080010192024-12-06
05051977003803Penlon4080010204080010202024-12-06
05051977003810Penlon4080010214080010212024-12-06
05051977003827Penlon4080010224080010222024-12-06
05051977003674Penlon4080010114080010112024-12-06
05051977003766Penlon4080010044080010042024-12-06
05051977000857PenlonPrima 460 Anaesthetic Machine50113052024-12-06
05051977001465PenlonSigma Delta Vaporizer / Halothane410502H2024-12-06
05051977002011PenlonSigma Delta Vaporizer / Isoflurane410502I2024-12-06
05051977002028PenlonSigma Delta Vaporizer / Sevoflurane410502S2024-12-06
05051977002035PenlonSigma Delta MRI Vaporizer / Sevoflurane410502S-M2024-12-06

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