FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756561778
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
47-514
Device description
ST SUTURE REMOVAL KIT
Published
2016-12-29
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
OVNSuture kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVNSuture KitGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756561773PackageGS150In Commercial Distribution
00749756561778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975656177350749756561773
00749756561778007497565617787497565617780749756561778

GMDN Terms#

Term, Definition table
TermDefinition
Suture kit, non-medicatedA collection of sterile instruments and dressings necessary to perform a suturing procedure; it does not contain any pharmaceuticals. It typically includes a disinfectant, needles and various threads (sutures used to join the edges of a wound or incision by stitching), drapes, swabs, needle holder, and other single-use disposable devices. This device may be used in a wide variety of clinical settings and some types may be used for the removal of sutures. 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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956299511CARDINAL HEALTHCardinal Health 200, LLCOVN2026-01-12
10198956201842CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-29
10198956299979CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-29
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10198956250055CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-17
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10198956241848CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-28
10198956284562CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-25
10198956284678CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-25
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10198956219205CARDINAL HEALTHCardinal Health 200, LLCOVN2025-10-20
10198956223288CARDINAL HEALTHCardinal Health 200, LLCOVN2025-10-20
10198956187450CARDINAL HEALTHCardinal Health 200, LLCOVN2025-10-03
10198956185128CARDINAL HEALTHCardinal Health 200, LLCOVN2025-09-23
10198956192881CARDINAL HEALTHCardinal Health 200, LLCOVN2025-09-22