FDA.report

Devon

Primary DI
10192253052602
Brand
Devon
Company
Cardinal Health 200, LLC
Model
31155107
Catalog number
31155107
Device description
Needle Counter
Published
2024-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
50192253052600PrimaryGS10
10192253052602Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019225305260050192253052600
1019225305260210192253052602

GMDN Terms

TermDefinition
Suturing needle holder, single-useA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It has short serrated jaws at the distal end to provide better grip of the needle, and 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. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
100
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
false

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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
20192253052227DevonCardinal 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