FDA.reportPublic FDA data

C-Sponge

Primary DI
D867CSIII1000
Brand
C-Sponge
Company
Xemax Surgical Products Inc
Model
III
Catalog number
CSIII100
Device description
Pharyngeal barrier
Published
2022-08-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
D867CSIII1000PrimaryHIBCC0
D867CSIII001Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Non-woven gauze padA non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) 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; in some cases, the device’s packaging may be used as a disposable tray. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
804495695
Device count
100
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D867CLEG0Etchant GelCLEGCLEG2017-05-22
D867CLEGS0Etchant Gel SyringeCLEGSCLEGS2017-05-22
D867CLABC0Aqua Bond CompositeCLABCCLABC2017-05-22
D867CLQSP0Quick Set Paste A & BCLQSPCLQSP2017-05-22
D867CLQSPA0Quick Set Paste ACLQSPACLQSPA2018-05-31
D867CLQSPB0Quick Set Paste BCLQSPBCLQSPB2018-05-31
D867RLH0Right Light RLHRLH2023-06-12
D867CLABP0Aqua Bond SealantCLABPCLABP2017-05-22
D867CSII1000C-SpongeIICSII1002022-08-08
D867CSIV1000C-SpongeIVCSIV1002022-08-08
D867CSP500C-SpongePedoCSP502022-08-08
D867CSR1000C-SpongeRegularCSR1002022-08-08
D867ELILG0Elbow ImmobilizerELILGELILG2023-06-12
D867ELISM0Elbow Immobilizer PedoELISMELISM2023-06-12
D867OSSF0Osseo II Bone TrapOSSFOSSF2023-06-12
D867CL36005Cusp-Lok 360CL360052022-09-09
D867CL36010Cusp-Lok 360CL360102022-09-09
D867CLCMLP05Cusp-Lok CMLPCLCM05LP2022-09-09
D867CLCMLP10Cusp-Lok CMLPCLCM10LP2022-09-09
D867CLCMR05Cusp-Lok CMRCLCM05R2022-09-09

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