FDA.reportPublic FDA data

Penlon

Primary DI
05051977003704
Brand
Penlon
Company
PENLON LTD
Model
408001014
Catalog number
408001014
Device description
BLADE MRI ENGLISH MACINTOSH 4
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
05051977003704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051977003704050519770037045051977003704

GMDN Terms#

Term, Definition table
TermDefinition
Laryngoscope blade, reusableThe 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 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
05051977003605Penlon4080010024080010022024-12-06
05051977003681Penlon4080010124080010122024-12-06
05051977003698Penlon4080010134080010132024-12-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06971834830597Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30