FDA.report

Adler Instrument Company

Primary DI
00810123200436
Brand
Adler Instrument Company
Company
Adler, Inc.
Model
ADB-18-10
Device description
Nh cvd rnd hdl w/o lok 7-1/8"
Published
2023-03-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FHQHolder, Needle, Gastroenterologic

Product Code Classifications

CodeDeviceSpecialtyClass
FHQHolder, Needle, GastroenterologicGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810123200436PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810123200436008101232004368101232004360810123200436

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
8772416747orders@theadlerinstruments.com

Regulatory Flags

DUNS number
830141235
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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00810123209866Adler Instrument Company32-55032026-03-03
00810123209873Adler Instrument Company32-55052026-03-03
00810123209880Adler Instrument Company32-55062026-03-03
00810123209897Adler Instrument Company32-55072026-03-03
00810123209903Adler Instrument Company32-55082026-03-03
00810123209910Adler Instrument Company32-55092026-03-03
00810123209927Adler Instrument Company70-04552026-03-03
00810123209934Adler Instrument CompanyAD11-10032026-03-03
00810123209941Adler Instrument CompanyAD24-60432026-03-03
00810123209958Adler Instrument Company200-2832026-03-03
00810123209965Adler Instrument Company30-03152026-03-03
00810123209972Adler Instrument CompanyAD21-23052026-03-03

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