FDA.reportPublic FDA data

MediChoice

Primary DI
50885632110489
Brand
MediChoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
FG3001
Device description
Holder Needle Webster 5 Inch Disposable Not Made With Natural Rubber Latex Sterile MediChoice
Published
2020-09-24
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

Product Codes#

Code, Name table
CodeName
KDCINSTRUMENT, SURGICAL, DISPOSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDCInstrument, Surgical, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885632110489PackageGS125In Commercial Distribution
10885632110481PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088563211048950885632110489
1088563211048110885632110481

GMDN Terms#

Term, Definition table
TermDefinition
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00
Special Storage Condition, Specify00Avoid Freezing and Excessive Heat

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007941230
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885632434266Halyard563482026-05-22
10885632434303Halyard563522026-05-22
10885632468490Halyard614862026-05-22
10885632468506Halyard614872026-05-22
10885632468513Halyard614882026-05-22
10885632468520Halyard614892026-05-22
10885632509032Halyard620732026-05-22
10885632509049Halyard620742026-05-22
10885632509056Halyard620752026-05-22
10885632509063Halyard620762026-05-22
10885632510199Halyard620772026-05-22
10885632521751SurgiTrackSM450130D17D2026-05-22
10885632521607SurgiTrackSM4500452F842026-05-19
10885632521638SurgiTrackSM45007841332026-05-19
10885632521522SurgiTrackSM4500410A672026-05-18
10885632521577SurgiTrackSM450041BC2C2026-05-18
10885632521584SurgiTrackSM45004117402026-05-18
10885632521591SurgiTrackSM45004113802026-05-18
10885632521317SurgiTrackSM450178CA972026-05-13
10885632434228Halyard563442026-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160500040Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.KDC2025-10-28
10198459343520MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDC2025-05-22
10192253052404DevonCardinal Health 200, LLCKDC2025-03-27
10653160385769MEDLINEMEDLINE INDUSTRIES, INC.KDC2025-01-29
10653160383208CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2024-12-03
10653160383123MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-11-21
10653160383130MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-11-21
10653160383147MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-11-21
10653160382119MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-11-04
10653160381501MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-10-18
10653160381228MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-10-11
10653160381334MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-10-11
10653160379874CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2024-09-11
10653160379232MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-08-28
10653160375128MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-05-28
10653160375340MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-05-28
10653160374183CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2024-05-02
10653160369592CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-12-18
10653160369462CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-12-11
10653160369431CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-12-08
10653160369448CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-12-08
10653160365815CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-09-05
10080196415472MedlineMEDLINE INDUSTRIES, INC.KDC2023-06-22
10705031470507MERSILENEETHICON, LLCKDC2023-05-30
10653160360766CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-05-29
10653160359197CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-03-17
10810102270921Dermapac, Inc.Dermapac Inc.KDC2022-09-12
10810102270938Dermapac, Inc.Dermapac Inc.KDC2022-09-12
10810102270945Dermapac, Inc.Dermapac Inc.KDC2022-09-12
10810102270952Dermapac, Inc.Dermapac Inc.KDC2022-09-12