FDA.report

Gauze Pad, Sterile

Primary DI
00616784335421
Brand
Gauze Pad, Sterile
Company
DYNAREX CORPORATION
Model
3354
Device description
Gauze Pad, Sterile, 1s, 4"x4", 12 ply
Published
2021-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications

CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784335421PackageGS1100In Commercial Distribution
00616784335438PackageGS112In Commercial Distribution
00616784335414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784335421006167843354216167843354210616784335421
00616784335438006167843354386167843354380616784335438
00616784335414006167843354146167843354140616784335414

GMDN Terms

TermDefinition
Woven gauze pad, sterileA non-medicated sterile 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
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
true
Sterilization required before use
false

Other Devices From This Company

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00616784710518Sphygmomanometer71052016-09-24
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00616784711423PA [SensiLance Pressure Activated Safety Lancets,Sterile71142021-05-21
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00616784709925Blood Pressure Kit,Sphymomanometer with Dual Head Stethoscope70992016-09-24
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00616784710228Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71022016-09-24
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00840117349711IV Extension Sets Needle-Free Luer Lock Connector For Injection, Non-Toxic, 17"70612016-09-24
00840117349742IV Extension Sets Needle-Free Luer Lock Connector, Non-Toxic, 8" (20.3 cm)70622016-09-24
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