FDA.reportPublic FDA data

Penlon

Primary DI
05051977003667
Brand
Penlon
Company
PENLON LTD
Model
408001010
Catalog number
408001010
Device description
BLADE MRI AMERICAN MACINTOSH 4
Published
2024-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
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
05051977003667PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051977003667050519770036675051977003667

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
458942687
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06971355350178BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350512BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350529BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350888BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
00190776427580MillenniumAvalign Technologies, Inc.CCW2026-08-26
00190776427597MillenniumAvalign Technologies, Inc.CCW2026-08-26
00190776427603MillenniumAvalign Technologies, Inc.CCW2026-08-26
00190776427610MillenniumAvalign Technologies, Inc.CCW2026-08-26
00198506094071ELMED INCORPORATEDELMED INCORPORATEDCCW2026-08-18
00190776422936MillenniumAvalign Technologies, Inc.CCW2026-08-03
14026704760548PILLINGTELEFLEX INCORPORATEDCCW2026-07-31
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