FDA.reportPublic FDA data

Exchange Select

Primary DI
10614299405384
Brand
Exchange Select
Company
Aafes
Model
614299405387
Device description
Rolled Gauze, 4 in x 2.5 yds (101 mm x 2.28 m) unstretched
Published
2020-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
10614299405384PackageGS172In Commercial Distribution
00614299405387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061429940538410614299405384
00614299405387006142994053876142994053870614299405387

GMDN Terms#

Term, Definition table
TermDefinition
Non-woven gauze rollA sterile device in the form of a long strip of stretchable, non-woven material (e.g., rayon/polyester), wound into a roll, 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18558234545xx@xx.xx

Regulatory Flags#

DUNS number
001695568
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00614299399877Exchange Select6142993998772020-08-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975675784750RESCUE RESSENTIALSEMSRUN GROUPNAB2026-09-22
00810194401671AiraAIRA, LLCNAB2026-08-26
06979931947972TempoXuchang Zhende Surgical Dressing Co., Ltd.NAB2026-08-21
06979032641168Thomas Jane MedicalHUZHOU JUNDA INDUSTRY CO., LTD.NAB2026-06-27
06979032641175Thomas Jane MedicalHUZHOU JUNDA INDUSTRY CO., LTD.NAB2026-06-27
00197344173993CURADMEDLINE INDUSTRIES, INC.NAB2026-06-24
00197344174006CURADMEDLINE INDUSTRIES, INC.NAB2026-06-24
00840456203330JMUJMU DENTAL, INCNAB2026-06-23
00840456203347JMUJMU DENTAL, INCNAB2026-06-23
00840456203354JMUJMU DENTAL, INCNAB2026-06-23
00840456224199JMUJMU DENTAL, INCNAB2026-06-23
00840456224205JMUJMU DENTAL, INCNAB2026-06-23
06924105625026BOENMEDBOEN HEALTHCARE CO., LTD.NAB2026-06-03
06924105625033BOENMEDBOEN HEALTHCARE CO., LTD.NAB2026-06-03
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