FDA.reportPublic FDA data

CurPro Surgical Sponges All Gauze

Primary DI
00616784334516
Brand
CurPro Surgical Sponges All Gauze
Company
Dynarex Corporation
Model
3345
Device description
" 4""x4"", 12-ply (10.2cm x 10.2cm)"
Published
2021-04-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00616784334530PackageGS1128In Commercial Distribution
00616784334516PrimaryGS10
00810180840187Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784334530006167843345306167843345300616784334530
00616784334516006167843345166167843345160616784334516
00810180840187008101808401878101808401870810180840187

GMDN Terms#

Term, Definition table
TermDefinition
Woven gauze pad, non-antimicrobialA non-medicated device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it does not include petrolatum. It is typically used to: clean, cover, or pack wounds or abrasions and absorb their exudates; absorb body-surface exudates; or apply topical medications. This is a single-use device.

Regulatory Flags#

DUNS number
008124539
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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00616784671628SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrou67162026-09-30
00616784671727SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrous67172026-09-30
00616784671826SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrous67182026-09-30
00616784671925SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrous67192026-09-30
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00840117346239Resp-O2 M15 Oxygen Standard D-Cylinder, With CGA 870 Post Valve36391-PBULK2026-09-28
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00840117352735dmecare Solutions Folding Beside Commode103702021-04-22
00840117352742dmecare Solutions Elongated Folding Bedside Commode103712021-04-22
00840117308855Resp-O2 Dry Bubble Humidifier, 6 PSI (Home Use), 400 mL342212022-05-11
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