FDA.reportPublic FDA data

Circumcision Kit

Primary DI
20886333220872
Brand
Circumcision Kit
Company
ARGON MEDICAL DEVICES, INC.
Model
AOB-1000A
Catalog number
AOB-1000A
Device description
Circumcision Kit
Published
2018-05-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OHGCircumcision Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHGCircumcision TrayObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886333220872PackageGS110In Commercial Distribution
00886333220878PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633322087220886333220872
00886333220878008863332208788863332208780886333220878

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA general-purpose collection of various sterile surgical instruments, dressings, and materials, including a pharmaceutical component, intended to be used to assist a range of surgical procedures across multiple clinical specialities. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags#

DUNS number
140727624
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886333003594Breast Localization Needles231075G231075G2022-07-05
00886333003600Breast Localization Needles231030G231030G2022-07-05
00886333003617Breast Localization Needles231050G231050G2022-07-05
00886333003624Breast Localization Needles231125G231125G2022-07-05
00886333003631Breast Localization Needles231100G231100G2022-07-05
00886333003648Breast Localization Needles2420502420502022-06-30
00886333003655Breast Localization Needles2420752420752022-06-30
00886333003662Breast Localization Needles2421002421002022-06-30
00886333003679Breast Localization Needles2421252421252022-06-29
00886333003686Breast Localization Needles2430752430752022-06-29
00886333003693Breast Localization Needles2431252431252022-07-05
00886333003709Breast Localization Needles2430502430502022-06-29
00886333003723Breast Localization Needles2430302430302022-06-29
00886333003730Breast Localization Needles2440302440302022-06-30
00886333003747Breast Localization Needles2440502440502022-06-30
00886333003754Breast Localization Needles2440752440752022-06-29
00886333003761Breast Localization Needles2441002441002022-06-30
00886333003778Breast Localization Needles2441252441252022-06-30
00886333003785Breast Localization Needles2511002511002022-06-29
00886333003792Breast Localization Needles2510752510752022-07-05

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Primary DI, Brand, Company table
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10198956487383CARDINAL HEALTHCardinal Health 200, LLCOHG2026-06-08
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10197106839775CARDINAL HEALTHCardinal Health 200, LLCOHG2025-05-27
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10197106795729CARDINAL HEALTHCardinal Health 200, LLCOHG2024-10-11
10197106739754CARDINAL HEALTHCardinal Health 200, LLCOHG2024-10-01
10197106661765CARDINAL HEALTHCardinal Health 200, LLCOHG2024-09-27
10197106755952CARDINAL HEALTHCardinal Health 200, LLCOHG2024-09-09
10197106732694CARDINAL HEALTHCardinal Health 200, LLCOHG2024-09-06
10197106745489CARDINAL HEALTHCardinal Health 200, LLCOHG2024-08-19