FDA.report

Dental City

Primary DI
D771461720
Brand
Dental City
Company
ICP, INC.
Model
46-172
Device description
Dental City 4x4 4-ply Non-Woven Gauze 35gm 2000/Case 22500
Published
2021-06-25
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
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
D77146172PrimaryHIBCC0
D771461720Unit of UseHIBCC0

GMDN Terms

TermDefinition
Non-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 non-woven material (e.g., rayon, polyester, cellulose pulp) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
808371371
Device count
2000
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
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D77114705LG0Stratus14-705LG2026-03-24
D77114705MD0Stratus14-705MD2026-03-24
D77114705SM0Stratus14-705SM2026-03-24
D77114705XL0Stratus14-705XL2026-03-24
D77114705XS0Stratus14-705XS2026-03-24
D7714227200BG0Dental City42-27200BG42-27200BG2026-03-24
D7714227200M0Dental City42-27200M42-27200M2026-03-24
D7714227200ML0Dental City42-27200ML2026-03-24
D771422750ML0Dental City42-2750ML2026-03-24
D77116100LG0Guardian16-100LG2026-03-19
D77116100MD0Guardian16-100MD2026-03-19
D77116100SM0Guardian16-100SM2026-03-19
D77116100XL0Guardian16-100XL2026-03-19
D77116100XS0Guardian16-100XS2026-03-19
D77114701LG0Dental City14-701LG2023-06-02
D77114701MD0Dental City14-701MD2023-06-02
D77114701SM0Dental City14-701SM2023-06-02
D77114701XL0Dental City14-701XL2023-06-02
D77114701XS0Dental City14-701XS2023-06-02
D77114715LG0Dental City14-715LG2023-06-02

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00851587006073XGAUZE Trauma PadRevmedx, Inc.NAB2026-02-25
20665973020918DukalDukal LLCNAB2026-01-30
20665973020932DukalDukal LLCNAB2026-01-30
00810194401763AiraAIRA, LLCNAB2026-01-16
00810194401770AiraAIRA, LLCNAB2026-01-16
00810194401787AiraAIRA, LLCNAB2026-01-16
00810194401824AiraAIRA, LLCNAB2026-01-16
00810194401831AiraAIRA, LLCNAB2026-01-16
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00810194401855AiraAIRA, LLCNAB2026-01-16
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00723896029589Practicon® Premium 2x2 Non-Woven Sponges 200/PackPRACTICON, INC.NAB2026-01-07
00723896029619Practicon® Standard 4x4 Non-Woven Sponges 200/PackPRACTICON, INC.NAB2026-01-07
00723896029640Practicon® Premium 4x4 Non-Woven Sponges 200/PackPRACTICON, INC.NAB2026-01-07
00840456217009JMUJMU DENTAL, INCNAB2025-12-31
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