FDA.report

Devon

Primary DI
10884527013166
Brand
Devon
Company
Cardinal Health, Inc.
Model
31155552
Catalog number
31155552
Device description
1810 Needle Counter
Published
2018-06-23
Public version status
Update
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

Contact Domains

Product Codes

CodeName
GABNEEDLE, SUTURING, DISPOSABLE

Product Code Classifications

CodeDeviceSpecialtyClass
GABNeedle, Suturing, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10884527013166PrimaryGS10
20884527013163Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088452701316610884527013166
2088452701316320884527013163

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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00;

Sterilization Methods

Method

Contacts

PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags

DUNS number
080935429
Device count
200
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

Other Devices From This Company

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30884521012497Monoject888120234888812023482018-06-27
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20884521012568Monoject888120239788812023972018-06-30
20884521142760Monoject10884521142763108845211427632018-06-29
00029369211032MCDAVIDMH794002112023-05-26
90884521162088Uni-PatchMH73912MH739122018-06-30

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
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