FDA.reportPublic FDA data

CONMED

Primary DI
00412786063870
Brand
CONMED
Company
UNIMAX MEDICAL SYSTEMS INC.
Model
CD004
Device description
Anti Fog
Published
2019-03-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery
OCTAnti Fog Solution And Accessories, Endoscopy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
OCTAnti Fog Solution And Accessories, EndoscopyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111622000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111622000UNIMAX ANTI-FOG SOLUTIONUnimax Medical Systems, Inc.2011-09-09OCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10412786063877PackageGS120Not in Commercial Distribution
14714127860890PackageGS120In Commercial Distribution
20412786063874PackageGS110Not in Commercial Distribution
24714127860897PackageGS110In Commercial Distribution
00412786063870PreviousGS10
04714127860893PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1041278606387710412786063877
1471412786089014714127860890
2041278606387420412786063874
2471412786089724714127860897
00412786063870004127860638704127860638700412786063870
04714127860893047141278608934714127860893

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height6Inch
Width3Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658122465
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15055515601558FemcareFN-100-105 2025-10-14
15055515601565FemcareFN-100-1062025-10-14
15055515601572FemcareFN-100-1072025-10-14
15055515601602FemcareFN-100-2092025-10-14
15055515601619FemcareFN-100-2102025-10-14
15055515601626FemcareFN-100-2112025-10-14
15055515602401FemcareFN-100-106-CA2025-10-14
15055515602418FemcareFN-100-210-CA2025-10-14
04714127861500UnimaxFEPC340802025-02-06
14714127861507UnimaxFEPC340802025-02-06
14714127866601UnimaxFPJ1330592021-08-10
14714127866700UnimaxFPL1330592021-08-10
14714127866809UnimaxFPS1330592021-08-10
04714127860732CONMED12222019-12-17
04714127860879CONMED12212019-12-17
04714127862972Monopolar scissorsFMS4330562018-04-02
04714127862996Monopolar scissorsFMS4330552017-11-29
04714127865980Monopolar scissorsFMS3330502017-09-18
04714127866000UnimaxFMS5330502020-11-18
04714127866239UnimaxFEC5330502021-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435493MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435547MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435295MillenniumAvalign Technologies, Inc.GCJ2026-10-19
00190776435455MillenniumAvalign Technologies, Inc.GCJ2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
04548736175013OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175068OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175112OLYMPUSSONY CORPORATIONGCJ2026-10-15
00190776434922MillenniumAvalign Technologies, Inc.GCJ2026-10-14
00190776434823MillenniumAvalign Technologies, Inc.GCJ2026-10-13
00190776434854MillenniumAvalign Technologies, Inc.GCJ2026-10-13
B382SD56300680Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
B382SD563006820Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
00190776434250MillenniumAvalign Technologies, Inc.GCJ2026-10-09
00848657078481AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00848657078498AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00190776433697MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433703MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433710MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433727MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433338MillenniumAvalign Technologies, Inc.GCJ2026-10-05
00190776433345MillenniumAvalign Technologies, Inc.GCJ2026-10-05
00190776433031MillenniumAvalign Technologies, Inc.GCJ2026-10-01
00190776433079MillenniumAvalign Technologies, Inc.GCJ2026-10-01