FDA.reportPublic FDA data

Exchange Select

Primary DI
00614299399877
Brand
Exchange Select
Company
Aafes
Model
614299399877
Device description
Rolled Gauze, 2 in x 2.5 yds (50 mm x 2.28 m) unstretched
Published
2020-08-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10614299399874PackageGS172In Commercial Distribution
00614299399877PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061429939987410614299399874
00614299399877006142993998776142993998770614299399877

GMDN Terms#

Term, Definition table
TermDefinition
Non-woven gauze roll/sheetA device in the form of a long length of stretchable, non-woven material (e.g., rayon/polyester), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
18558234545xx@xx.xx

Regulatory Flags#

DUNS number
001695568
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00614299896338Exchange Select6142998963382023-09-04
00614299400511Exchange Select150-605-000150-605-0002016-09-12
00614299399884Exchange Select6142993998842020-08-21
00614299405394Exchange Select6142994053942020-08-21
00614299405400Exchange Select6142994054002020-08-21
10614299896335Exchange Select6142998963382023-09-04
00614299896291Exchange Select6142998962912023-05-18
10614299896298Exchange Select6142998962912023-05-18
00614299405387Exchange Select6142994053872020-08-21
00614299999152Exchange Select6142999991522020-08-10
00614299381025Exchange Select6142993810252021-07-19
00614299725690Exchange Select6142997256902020-08-21
00614299725867Exchange Select6142997258672020-08-21
00614299396371Exchange Select TamponsBAFAS202016-09-20
00614299396388Exchange Select TamponsBAFAR202016-09-20
00614299396401Exchange Select TamponsBAFAC402016-09-20
00614299402058Exchange Select TamponsBAFGR202016-09-20
00614299402065Exchange Select TamponsBAFGS182016-09-20
00614299405370Exchange Select6142994053702020-08-21
00614299407169Exchange Select TamponsBAFUR182016-09-20

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Primary DI, Brand, Company table
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