FDA.reportPublic FDA data

Adler Instrument Company

Primary DI
00810123206032
Brand
Adler Instrument Company
Company
Adler, Inc.
Model
22-1121
Device description
Halsey Needle Holder
Published
2023-07-12
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
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810123206032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810123206032008101232060328101232060320810123206032

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
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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
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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

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Primary DI, Brand, Company table
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