FDA.report

Devon

Primary DI
20192253052227
Brand
Devon
Company
Cardinal Health 200, LLC
Model
31142238
Catalog number
31142238
Device description
Needle Counter, 1540 Double Magnet White
Published
2025-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GABNEEDLE, SUTURING, DISPOSABLE

Product Code Classifications

CodeDeviceSpecialtyClass
GABNeedle, Suturing, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20192253052227PackageGS112In Commercial Distribution
50192253052228PackageGS18In Commercial Distribution
10192253052220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019225305222720192253052227
5019225305222850192253052228
1019225305222010192253052220

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

Regulatory Flags

DUNS number
961027315
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
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10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06931918157019AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2026-01-21
07350154050004SutureTOOLSuturion ABGAB2025-12-15
26931918179855AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2025-06-21
06931918144941AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2025-06-20
20192253052326DevonCardinal Health 200, LLCGAB2025-05-29
50192253052136DevonCardinal Health 200, LLCGAB2025-03-27
20192253052142DevonCardinal Health 200, LLCGAB2025-03-27
50192253052150DevonCardinal Health 200, LLCGAB2025-03-27
20192253052166DevonCardinal Health 200, LLCGAB2025-03-27
50192253052174DevonCardinal Health 200, LLCGAB2025-03-27
20192253052180DevonCardinal Health 200, LLCGAB2025-03-27
20192253052197DevonCardinal Health 200, LLCGAB2025-03-27
50192253052204DevonCardinal Health 200, LLCGAB2025-03-27
20192253052210DevonCardinal Health 200, LLCGAB2025-03-27
20192253052234DevonCardinal Health 200, LLCGAB2025-03-27
50192253052242DevonCardinal Health 200, LLCGAB2025-03-27
50192253052259DevonCardinal Health 200, LLCGAB2025-03-27
50192253052266DevonCardinal Health 200, LLCGAB2025-03-27
20192253052272DevonCardinal Health 200, LLCGAB2025-03-27
50192253052280DevonCardinal Health 200, LLCGAB2025-03-27
20192253052296DevonCardinal Health 200, LLCGAB2025-03-27
50192253052310DevonCardinal Health 200, LLCGAB2025-03-27
50192253052334DevonCardinal Health 200, LLCGAB2025-03-27
20192253052340DevonCardinal Health 200, LLCGAB2025-03-27
20192253052357DevonCardinal Health 200, LLCGAB2025-03-27
50192253052365DevonCardinal Health 200, LLCGAB2025-03-27
50192253052372DevonCardinal Health 200, LLCGAB2025-03-27
50192253052389DevonCardinal Health 200, LLCGAB2025-03-27
50192253053355DevonCardinal Health 200, LLCGAB2025-03-27
50192253053461DevonCardinal Health 200, LLCGAB2025-03-27