FDA.reportPublic FDA data

Adler Instrument Company

Primary DI
00810123207084
Brand
Adler Instrument Company
Company
Adler, Inc.
Model
AI-611
Device description
Zumi 4.5 Uterine Manipulator/Injector
Published
2024-04-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEACannula, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810123207084PrimaryGS10
00810123207176SecondaryNDC/NHRIC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810123207084008101232070848101232070840810123207084

GMDN Terms#

Term, Definition table
TermDefinition
Drug-delivery iontophoresis patchA non-sterile device designed as a patch that is fixed on the skin, typically with a pressure-sensitive adhesive, intended to be used as an alternative to injections for the transport of ionic-solution medication (e.g., soluble salts) through the movement of ions, resulting from an applied electric field, to locally administer the medication transcutaneously (transdermal). It typically consists of a positive and a negative electrode, a reservoir/drug chamber(s) that hold the medication, a battery, and a perimeter adhesive; the reservoir must be filled by the user with the drug prior to use. This is a single-use device.

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00810220800485Adler Instrument Company310-3832026-07-17
00810220800492Adler Instrument CompanyADCH8200-302026-07-17
00810220800447Adler Instrument CompanyAD24-47602026-06-24
00810220800294Adler Instrument Company38-51402026-06-02
00810220800300Adler Instrument Company50-02602026-06-02
00810220800317Adler Instrument CompanyAD760159232026-06-02
00810220800324Adler Instrument CompanyAD106-1412026-06-02
00810220800331Adler Instrument CompanyAD20-21412026-06-02
00810220800348Adler Instrument Company320-4312026-06-02
00810220800355Adler Instrument Company20-32202026-06-02
00810220800362Adler Instrument Company19-92622026-06-02
00810220800089Adler Instrument Company38-4985CC2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130456789Medco ManufacturingMedco Manufacturing LLCGEA2026-08-25
00810130456796Medco ManufacturingMedco Manufacturing LLCGEA2026-08-25
00810130456819Medco ManufacturingMedco Manufacturing LLCGEA2026-08-25
00190776419066MillenniumAvalign Technologies, Inc.GEA2026-08-23
00190776419639MillenniumAvalign Technologies, Inc.GEA2026-08-23
00850012846741JNW URTRACLSI Solutions, Inc.GEA2026-08-21
00884450681329Preston™Merit Medical Systems, Inc.GEA2026-08-21
00884450681336Preston™Merit Medical Systems, Inc.GEA2026-08-21
00884450681343Preston™Merit Medical Systems, Inc.GEA2026-08-21
00884450681350Preston™Merit Medical Systems, Inc.GEA2026-08-21
04054462902583evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902590evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902606evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902613evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902620evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902637evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902644evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902651evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902668evonosevonos GmbH & Co. KGGEA2026-08-21
00190776417062MillenniumAvalign Technologies, Inc.GEA2026-08-18
00190776407506MillenniumAvalign Technologies, Inc.GEA2026-07-31
00840329838409BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-07-30
00840329838416BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-07-30
00840329838430BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-07-30
00840329838454BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-07-30
00840329838515BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-07-30
00810130456710Medco ManufacturingMedco Manufacturing LLCGEA2026-07-23
00810130456727Medco ManufacturingMedco Manufacturing LLCGEA2026-07-23
00810130456734Medco ManufacturingMedco Manufacturing LLCGEA2026-07-23
00810130456741Medco ManufacturingMedco Manufacturing LLCGEA2026-07-23