FDA.reportPublic FDA data

Adler Instrument Company

Primary DI
00810123206582
Brand
Adler Instrument Company
Company
Adler, Inc.
Model
41-0395
Device description
"Garrett Vascular Dilator Set of 9 OL 139mm (5-1/2"")"
Published
2023-12-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWPDilator, Vessel, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWPDilator, Vessel, SurgicalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100518000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100518000INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054Instrumed International, Inc.2010-08-31DWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810123206582PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810123206582008101232065828101232065820810123206582

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8772416747orders@theadlerinstruments.com

Regulatory Flags#

DUNS number
830141235
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810220800683Adler Instrument Company54-70692026-11-05
00810220800676Adler Instrument CompanyAD13-00642026-10-28
00810220800638Adler Instrument CompanyAD50-51042026-10-15
00810220800645Adler Instrument CompanyAD11-07012026-10-15
00810220800652Adler Instrument CompanyAD30-21552026-10-15
00810220800669Adler Instrument Company30-21562026-10-15
00810220800591Adler Instrument CompanyS63882026-10-07
00810220800607Adler Instrument CompanyS63872026-10-07
00810220800614Adler Instrument CompanyS63922026-10-07
00810220800621Adler Instrument CompanyAD1211302026-10-07
00810220800577Adler Instrument Company42-02932026-09-30
00810220800584Adler Instrument CompanyAD32-110L2026-09-30
00810220800539Adler Instrument Company1682032026-08-18
00810220800546Adler Instrument Company48-51002026-08-18
00810220800553Adler Instrument Company48-01502026-08-18
00810220800508Adler Instrument CompanyAD2029-462026-07-30
00810220800515Adler Instrument CompanyADR-28092026-07-30
00810220800454Adler Instrument Company23-56152026-07-17
00810220800461Adler Instrument Company42-01742026-07-17
00810220800478Adler Instrument Company38-04702026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776400347MillenniumAvalign Technologies, Inc.DWP2026-07-17
B382SD9081971000Surgical DirectSurgical Direct, Inc.DWP2026-07-17
B382SD9081971010Surgical DirectSurgical Direct, Inc.DWP2026-07-17
B382SD9081971020Surgical DirectSurgical Direct, Inc.DWP2026-07-17
B382SD9081971030Surgical DirectSurgical Direct, Inc.DWP2026-07-17
B382SD9081971040Surgical DirectSurgical Direct, Inc.DWP2026-07-17
B382S8711000Surgical DirectSurgical Direct, Inc.DWP2026-07-14
B382S8711010Surgical DirectSurgical Direct, Inc.DWP2026-07-14
B382S8711020Surgical DirectSurgical Direct, Inc.DWP2026-07-14
00192896123359Sarns Myocardial DilatorSONTEC INSTRUMENTS, INC.DWP2026-04-23
14026704927873PILLINGTELEFLEX INCORPORATEDDWP2025-09-30
14026704927880PILLINGTELEFLEX INCORPORATEDDWP2025-09-30
14026704927897PILLINGTELEFLEX INCORPORATEDDWP2025-09-30
14026704927903PILLINGTELEFLEX INCORPORATEDDWP2025-09-30
04058749118780NAFehling Instruments GmbH & Co. KGDWP2024-01-08
34026704652618PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704652625PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704652632PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704652649PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704652656PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704652670PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704652687PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704655961PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704652663PILLINGTELEFLEX INCORPORATEDDWP2020-03-23
00192896010703GARRETT VASCULAR DILATORSONTEC INSTRUMENTS, INC.DWP2018-08-29
00192896005563GARRETT VASCULAR DILATORSONTEC INSTRUMENTS, INC.DWP2018-08-24
00192896010680GARRETT VASCULAR DILATORSONTEC INSTRUMENTS, INC.DWP2018-08-24
00192896010697GARRETT VASCULAR DILATORSONTEC INSTRUMENTS, INC.DWP2018-08-24
00192896010710TUNNELERSONTEC INSTRUMENTS, INC.DWP2018-08-24
00192896010727TUBBS MITRAL VALVE DILATORSONTEC INSTRUMENTS, INC.DWP2018-08-24