FDA.report

Eddie Bauer

Primary DI
00888989307262
Brand
Eddie Bauer
Company
Charmant USA Inc.
Model
39445R
Catalog number
39445R200AS
Device description
Eddie Bauer Assortd 52/16 140M Reader Men
Published
2022-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HOISpectacle, Magnifying

Product Code Classifications

CodeDeviceSpecialtyClass
HOISpectacle, MagnifyingOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888989307262PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888989307262008889893072628889893072620888989307262

GMDN Terms

TermDefinition
Magnifying spectaclesA device that consists of a spectacle frame with convex lenses intended to enlarge text/images for a visually impaired patient/person. It is made of plastic material or glass within a plastic or metal frame.

Sterilization Methods

Method

Regulatory Flags

DUNS number
944350339
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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 DIBrandModelCatalogPublished
00888989065964Eddie Bauer39413P39413P55BK2023-02-01
00888989065971Eddie Bauer39413P39413P55TT2023-02-01
00888989171535Eddie Bauer39406P39406P54CL2022-12-01
00888989180681Elle149131491354BK2022-12-01
00888989180698Elle149131491354BR2022-12-01
00888989180704Elle149131491354GN2022-12-01
00888989180728Elle149141491455BK2022-12-01
00888989180735Elle149141491455BL2022-12-01
00888989180742Elle149141491455BR2022-12-01
00888989180766Elle149151491555BK2022-12-01
00888989180773Elle149151491555GR2022-12-01
00888989180780Elle149151491555PK2022-12-01
00888989180841Elle149171491758BK2022-12-01
00888989180865Elle149171491758PU2022-12-01
00888989180872Elle149171491758RE2022-12-01
00888989180889Elle149181491855BK2022-12-01
00888989180896Elle149181491855BR2022-12-01
00888989180902Elle149181491855PU2022-12-01
00888989180933Elle149191491954BL2022-12-01
00888989180940Elle149191491954BR2022-12-01

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