FDA.report

Henry Schein

Primary DI
00304040153604
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5702636
Catalog number
5702636
Device description
Exodontia Sponge Filled N/S 2X2
Published
2021-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EFNCOTTON, ROLL

Product Code Classifications

CodeDeviceSpecialtyClass
EFNCotton, RollDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10304040153601PrimaryGS10
00304040153604Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404015360110304040153601
00304040153604003040401536043040401536040304040153604

GMDN Terms

TermDefinition
Woven gauze pad, non-sterileA non-medicated, non-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 cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
012430880
Device count
5000
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

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00304040187555Zirlux920005592000552026-02-04
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00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

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