FDA.reportPublic FDA data

Dr. Fog® Solution With Sponge

Primary DI
00840113200580
Brand
Dr. Fog® Solution With Sponge
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
DF-3100
Device description
Intended to be used as an anti-fog agent for endoscopic camera lenses
Published
2021-02-25
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
OCTAnti fog solution and accessories, endoscopy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCTAnti Fog Solution And Accessories, EndoscopyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K932449000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K932449000DR. FOGO.R. Concepts, Inc.1993-08-11OCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840113200573PackageGS120In Commercial Distribution
00840113200580PackageGS115In Commercial Distribution
00840113200597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840113200573008401132005738401132005730840113200573
00840113200580008401132005808401132005800840113200580
00840113200597008401132005978401132005970840113200597

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic antifog solutionA liquid substance used to prevent the occurrence of condensed vapour (fog) on the lens of an endoscopic instrument during treatment. It will typically be used on the lens of an endoscopic camera where the warmth from an enclosed body cavity creates the conditions to produce fog on the lens. This device will typically be contained in a spray can, bottle, or squeeze bottle. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(616)698-7100customerservice@aspensurgical.com

Regulatory Flags#

DUNS number
027680821
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840113233762Bovie Derm 1022026-05-11
00607151010263BovieA1250SA1250S2018-02-23
00840113244232ValleylabE15594E155942026-05-04
00840113244249ValleylabE15596E155962026-05-04
00840113244256ValleylabE15604E156042026-05-04
00840113244263ValleylabE15606E156062026-05-04
00840113244270ValleylabE15614E156142026-05-04
00840113244287ValleylabE15616E156162026-05-04
00840113244294ValleylabE15624E156242026-05-04
00840113244300ValleylabE15626E156262026-05-04
00840113244317ValleylabE15644E156442026-05-04
00840113244324ValleylabE15646E156462026-05-04
00840113244331ValleylabE16512 E16512 2026-05-04
00840113244348ValleylabE16514E165142026-05-04
00887482188873BovieA23502024-09-27
00887482188897BovieA33502024-09-27
00887482181324BovieIDS-2102024-08-26
00887482181508BovieIDS-3102024-08-26
00887482182536BovieA9422024-08-26
00887482182550BovieA9522024-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
27290019426053Plasma ShieldPlasmatica Ltd.OCT2025-12-15
04714127863153blue endoUNIMAX MEDICAL SYSTEMS INC.OCT2024-06-20
14714127863150blue endoUNIMAX MEDICAL SYSTEMS INC.OCT2024-06-20
10195327105365Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OCT2023-10-29
40195327105366Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OCT2023-10-29
10080196693450MedlineMEDLINE INDUSTRIES, INC.OCT2023-10-13
40080196693451MedlineMEDLINE INDUSTRIES, INC.OCT2023-10-13
27290019426008Plasma ShieldPlasmatica Ltd.OCT2023-05-17
27290019426022Plasma ShieldPlasmatica Ltd.OCT2023-05-17
00840113200597Dr. Fog® Solution With SpongeASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113200627Dr. Fog® Anti-fog SolutionASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113200863Aspen® Anti-fog SolutionASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113206896Dr. Fog® Treated SpongeASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113206926Dr. Fog® Treated SpongeASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113214105Leonhard Lang/Fannin Anti-Fog Kit; SterileASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113200603Dr. Fog® Anti-fog SolutionASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113200870Aspen® Anti-fog SolutionASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113206902Dr. Fog® Treated SpongeASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113206957Dr. Fog® Treated SpongeASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113214099Leonhard Lang/Fannin Anti-Fog Kit; SterileASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113214822Medline Anti-Fog, SterileASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113230433ArcRoyal Anti-Fog, Regular Solution, SterileASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
04714127860893CONMEDUNIMAX MEDICAL SYSTEMS INC.OCT2019-12-17
20326053102626Regard™Resource Optimization & Innovation, L.L.C.OCT2019-10-30
10326053102629Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.OCT2019-10-30
09349967002032AntiFogORTHE O R COMPANY PTY LTDOCT2019-09-25
09349967002056AntiFogORTHE O R COMPANY PTY LTDOCT2019-09-25
10885380166204CARDINAL HEALTHCardinal Health 200, LLCOCT2019-08-08
00849771037859Key Surgical Mr. Clear Anti-FogKEY SURGICAL, INC.OCT2019-07-24
10849771037856Key Surgical Mr. Clear Anti-FogKEY SURGICAL, INC.OCT2019-07-24