FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756741392
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
89-7548
Device description
MYRINGOTOMY PACK-LF
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OGSMyringotomy procedure kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGSMyringotomy Procedure KitEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756741397PackageGS110In Commercial Distribution
00749756741392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975674139750749756741397
00749756741392007497567413927497567413920749756741392

GMDN Terms#

Term, Definition table
TermDefinition
ENT surgical procedure kit, non-medicated, single-useA collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. This is a single-use device.

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
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00749756402545DeRoyal25-0103EU25-0103EU2026-07-08
00749756402552DeRoyal25-0103EUN25-0103EUN2026-07-08
00749756402569DeRoyal25-0104EU25-0104EU2026-07-08
00749756402576DeRoyal25-0104EUN25-0104EUN2026-07-08
00749756402583DeRoyal25-0105EU25-0105EU2026-07-08
00749756402590DeRoyal25-0108EU25-0108EU2026-07-08
00749756402606DeRoyal25-0201EU25-0201EU2026-07-08
00749756402613DeRoyal25-0401EU25-0401EU2026-07-08
00749756402620DeRoyal25-0401EUN25-0401EUN2026-07-08
00749756402637DeRoyal25-0402EU25-0402EU2026-07-08
00749756402644DeRoyal25-0402EUN25-0402EUN2026-07-08
00749756402651DeRoyal25-0403EU25-0403EU2026-07-08
00749756402675DeRoyal25-0801EU25-0801EU2026-07-08
00749756402682DeRoyal25-0802EU25-0802EU2026-07-08
00749756402712DeRoyal25-1108EU25-1108EU2026-07-08
00749756402729DeRoyal25-1108EUN25-1108EUN2026-07-08
00749756402736DeRoyal25-1401EU25-1401EU2026-07-08
00749756402743DeRoyal25-1401EUN25-1401EUN2026-07-08
00749756402774DeRoyal25-1403EUN25-1403EUN2026-07-08
00749756402538DeRoyal25-0101EUN25-0101EUN2026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956374195CARDINAL HEALTHCardinal Health 200, LLCOGS2026-04-14
10198956403369CARDINAL HEALTHCardinal Health 200, LLCOGS2026-03-19
50198956403367CARDINAL HEALTHCardinal Health 200, LLCOGS2026-03-19
10198956358874CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-23
10198956369054CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-23
50198956358872CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-23
50198956369052CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-23
10198956317628CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-13
50198956317626CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-13
00191072241351ACSAMERICAN CONTRACT SYSTEMS, INC.OGS2026-01-06
10198956261679CARDINAL HEALTHCardinal Health 200, LLCOGS2025-12-17
50198956261677CARDINAL HEALTHCardinal Health 200, LLCOGS2025-12-17
10198956223479CARDINAL HEALTHCardinal Health 200, LLCOGS2025-10-23
10198956180819CARDINAL HEALTHCardinal Health 200, LLCOGS2025-08-27
50198956180817CARDINAL HEALTHCardinal Health 200, LLCOGS2025-08-27
10198956132733CARDINAL HEALTHCardinal Health 200, LLCOGS2025-07-31
50198956132731CARDINAL HEALTHCardinal Health 200, LLCOGS2025-07-31
10198956111936CARDINAL HEALTHCardinal Health 200, LLCOGS2025-06-30
50198956111934CARDINAL HEALTHCardinal Health 200, LLCOGS2025-06-30
10198956117242CARDINAL HEALTHCardinal Health 200, LLCOGS2025-06-16
50198956117240CARDINAL HEALTHCardinal Health 200, LLCOGS2025-06-16
10197106858844CARDINAL HEALTHCardinal Health 200, LLCOGS2025-05-29
50197106858842CARDINAL HEALTHCardinal Health 200, LLCOGS2025-05-29
10198956079984CARDINAL HEALTHCardinal Health 200, LLCOGS2025-05-21
50198956079982CARDINAL HEALTHCardinal Health 200, LLCOGS2025-05-21
10198956060364CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-29
50198956060362CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-29
10197106988398CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-25
10198956060449CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-25
50197106988396CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-25