FDA.reportPublic FDA data

Modulap

Primary DI
00817428021513
Brand
Modulap
Company
ATC TECHNOLOGIES, INC.
Model
4599
Device description
ADAPTER; FEMALE END TO FEMALE END
Published
2025-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K983623000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983623000MODULAPAtc Technologies, Inc.1998-12-18GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817428021513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817428021513008174280215138174280215130817428021513

GMDN Terms#

Term, Definition table
TermDefinition
Luer/Luer linear connector, reusableA small, non-powered, noninvasive, tubular, two-way/linear connector with a Luer connection (either lock or slip) at both ends intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape and may include a very short length of tube between each Luer connection; it does not incorporate a filter, valve, clamp, nor puncturing component. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023131605
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817428021537Modulap347934792026-04-14
00817428021544Modulap31562026-04-14
00817428021551Modulap45832026-03-20
10817428021558Modulap45832026-03-20
00817428021490Modulap31302025-07-21
00817428021506Modulap40422025-07-21
00817428021520Modulap312831282025-07-21
10817428021503Modulap40422025-07-21
10817428021510Modulap45992025-05-07
00817428021469Modulap41402025-03-26
10817428021022Modulap41412025-03-26
10817428021046Modulap41432025-03-26
10817428021053Modulap41442025-03-26
00817428021018Modulap414041402019-08-15
00817428021025Modulap414141412019-08-15
00817428021032Modulap414241422019-08-15
00817428021049Modulap414341432019-08-15
00817428021056Modulap414441442019-08-15
10817428021480MODULAP45812024-12-17
00817428021483Modulap45812024-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776427931MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428051MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428303MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776427429MillenniumAvalign Technologies, Inc.GCJ2026-08-26
04580826928451PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928543PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928581PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928604PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
08800035701499CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701505CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701512CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701529CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701536CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701543CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701949CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701956CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701963CORE-TrocarINCORE CO., LTDGCJ2026-08-25
B382SD13448970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD16008970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD161730Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205052000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205082000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD7720508TS2000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205252000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
00190776425883MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425906MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425968MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425975MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426361MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426378MillenniumAvalign Technologies, Inc.GCJ2026-08-18