FDA.reportPublic FDA data

Adler Instrument Company

Primary DI
00810123208395
Brand
Adler Instrument Company
Company
Adler, Inc.
Model
AD50-5645
Device description
"Blade Retractor, double ended, TW 8mm TW 10.5mm OL 110mm (4-1/4"")"
Published
2025-01-27
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
KALRetractor, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KALRetractor, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810123208395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810123208395008101232083958101232083950810123208395

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable 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
00724995327408V. MuellerSTERIS Deutschland GmbHKAL2026-09-25
00724995327422V. MuellerSTERIS Deutschland GmbHKAL2026-09-25
00841536148602ThompsonThompson Surgical Instruments, Inc.KAL2026-09-20
00841536148619ThompsonThompson Surgical Instruments, Inc.KAL2026-09-20
00841536148626ThompsonThompson Surgical Instruments, Inc.KAL2026-09-20
00841536148633ThompsonThompson Surgical Instruments, Inc.KAL2026-09-20
00190776429065MillenniumAvalign Technologies, Inc.KAL2026-09-04
04054462156498evonosevonos GmbH & Co. KGKAL2026-08-26
04054462156504evonosevonos GmbH & Co. KGKAL2026-08-26
04054462913039evonosevonos GmbH & Co. KGKAL2026-08-26
00190776417253MillenniumAvalign Technologies, Inc.KAL2026-08-19
00190776417710MillenniumAvalign Technologies, Inc.KAL2026-08-19
04054462913060evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913077evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913091evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913107evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913114evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913121evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913138evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913145evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913169evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913213evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913237evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913251evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913275evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913152evonosevonos GmbH & Co. KGKAL2026-08-18
04054462915828evonosevonos GmbH & Co. KGKAL2026-08-17
04054462915835evonosevonos GmbH & Co. KGKAL2026-08-17
04054462915842evonosevonos GmbH & Co. KGKAL2026-08-17
04054462915859evonosevonos GmbH & Co. KGKAL2026-08-17