FDA.report

DeRoyal

Primary DI
30749756329249
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
30-860
Catalog number
30-860
Device description
Suture Packet Organizer
Published
2021-06-30
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

Related Records

Contact Domains

Product Codes

CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30749756329249PackageGS112In Commercial Distribution
50749756329243PackageGS124In Commercial Distribution
00749756329248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3074975632924930749756329249
5074975632924350749756329243
00749756329248007497563292487497563292480749756329248

GMDN Terms

TermDefinition
Surgical instrument containment holder, single-use, sterileA sterile device intended to be used in the operating room (OR) by staff to safely contain a delicate or sharp hand-held, manual, surgical instrument(s) [e.g., needle, scalpel, scissors] during surgery, to avoid damage to the instrument, and/or for temporary storage (e.g., to enable easy transfer/handling of the instrument at reduced risk of injury). It is available in various forms (e.g., rack, puncture cushion, telescopic tube, magnetic mat), and may be attached to a surgical drape; it is not a numbered tray and is not intended for counting of sharps. This is a single-use device.

Sterilization Methods

Method

Contacts

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 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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07898663491562HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663493108HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663493467HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663495263HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663495270HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663495751HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663496239HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663497267HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663498080HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663498097HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663499292HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663499926HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663499957HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663499971HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089802307HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089803113HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089803441HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089804349HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089804950HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089806367HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089806626HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089807012HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089807029HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089807999HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089808583HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089808682HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089808729HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089809511HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089809528HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089809535HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24