FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756980413
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
89-10123
Catalog number
89-10123
Device description
AMNIOCENTESIS TRAY
Published
2021-07-12
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
HIOSampler, amniotic fluid (amniocentesis tray)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIOSampler, Amniotic Fluid (Amniocentesis Tray)Obstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756980413PackageGS116In Commercial Distribution
00749756980418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975698041350749756980413
00749756980418007497569804187497569804180749756980418

GMDN Terms#

Term, Definition table
TermDefinition
Amniocentesis kit, non-medicatedA collection of sterile devices designed to aspirate and contain a sample of amniotic fluid from the amniotic sac, via a transabdominal approach, for analysis. Components typically include a needle with stylet and syringe, specimen containers/medium, drapes, and dressings. The device is typically used at 16-18 weeks gestation for antepartum diagnosis of certain congenital abnormalities (e.g., Down syndrome, spina bifida), or anytime after 24-weeks gestation to assess foetal maturity. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
true
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
50749756033140DeRoyal10-513010-51302023-01-31
50749756392490DeRoyalNP-6006UNP-6006U2026-01-22
50749756397808DeRoyalNP-0080LMDNP-0080LMD2026-01-22
00749756401258DeRoyalSTM2000STM20002026-01-22
50749756401352DeRoyalM60-AP500M60-AP5002026-01-22
50749756401376DeRoyalM60-AP600M60-AP6002026-01-22
50749756401383DeRoyalM60-AP601M60-AP6012026-01-22
50749756401390DeRoyalM60-AP602M60-AP6022026-01-22
50749756401482DeRoyal46-LT19S-01B46-LT19S-01B2026-01-22
50749756401437DeRoyalM70-200PM70-200P2026-01-01
50749756401444DeRoyalM70-200CM70-200C2026-01-01
50749756401451DeRoyalM70-200CNWM70-200CNW2026-01-01
50749756401468DeRoyalM70-200PNWM70-200PNW2026-01-01
50749756394418DeRoyal71-080571-08052025-08-13
50749756396641DeRoyalPH81-010400PH81-0104002025-08-13
50749756397853DeRoyalPH81-020409PH81-0204092025-08-13
50749756397860DeRoyalPH81-020412PH81-0204122025-08-13
00749756399333DeRoyal1-524A-01-CHO1-524A-01-CHO2025-07-30
00749756399340DeRoyal1-524A-02-CHO1-524A-02-CHO2025-07-30
00749756399357DeRoyal1-524A-03-CHO1-524A-03-CHO2025-07-30

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Primary DI, Brand, Company table
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50197106799572CARDINAL HEALTHCardinal Health 200, LLCHIO2024-10-31
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50197106784455CARDINAL HEALTHCardinal Health 200, LLCHIO2024-10-03
50197106704903CARDINAL HEALTHCardinal Health 200, LLCHIO2024-07-09
50197106602421CARDINAL HEALTHCardinal Health 200, LLCHIO2024-04-16
50197106615193CARDINAL HEALTHCardinal Health 200, LLCHIO2024-04-16
00191072215246ACSAMERICAN CONTRACT SYSTEMS, INC.HIO2024-01-12
50197106448692CARDINAL HEALTHCardinal Health 200, LLCHIO2023-12-19
10849233013763Busse Hospital DisposablesROBERT BUSSE & CO., INC.HIO2023-12-12
25060259071304AmnicatorsMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDHIO2023-10-05
05060259071317AmnicatorsMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDHIO2023-10-05
50197106421404CARDINAL HEALTHCardinal Health 200, LLCHIO2023-09-08
50197106234790CARDINAL HEALTHCardinal Health 200, LLCHIO2023-05-23
50197106089000CARDINAL HEALTHCardinal Health 200, LLCHIO2023-02-24
10849233008820Busse Hospital DisposablesROBERT BUSSE & CO., INC.HIO2022-11-14
50195594770226CARDINAL HEALTHCardinal Health 200, LLCHIO2022-10-27
M75257030591Stradis STRADIS MEDICAL, LLCHIO2022-08-09
20886333220797Amniocentesis TrayARGON MEDICAL DEVICES, INC.HIO2022-07-20
20886333220803Amniocentesis TrayARGON MEDICAL DEVICES, INC.HIO2022-07-20
20886333224306Amniocentesis TrayARGON MEDICAL DEVICES, INC.HIO2022-07-20
50195594688415CARDINAL HEALTHCardinal Health 200, LLCHIO2022-07-07
50195594673848CARDINAL HEALTHCardinal Health 200, LLCHIO2022-05-13
H65857030591Henry ScheinHENRY SCHEIN, INC.HIO2022-04-26
M75257026860STRADIS HEALTHCARESTRADIS MEDICAL, LLCHIO2022-03-10
M75257014560STRADIS HEALTHCARESTRADIS MEDICAL, LLCHIO2022-03-07
50888439858370CARDINAL HEALTHCardinal Health 200, LLCHIO2022-01-07