FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756034604
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
32-1178
Catalog number
32-1178
Device description
ST. Ziplock Bag
Published
2021-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDCINSTRUMENT, SURGICAL, DISPOSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDCInstrument, Surgical, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756034604PackageGS150In Commercial Distribution
00749756034609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975603460450749756034604
00749756034609007497560346097497560346090749756034609

GMDN Terms#

Term, Definition table
TermDefinition
Instrument management bagA flexible plastic container intended to hold/collect instruments, cables, or other equipment during a surgical procedure or other clinical intervention, typically being attached to a drape or other support close to or inside the sterile field of operation/intervention. It may have a variety of designs, e.g., number of pouches, adhesive/non-adhesive, overall shape and size. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887482138373SterionASPEN SURGICAL PRODUCTS, INC.KDC2026-02-15
10653160391098Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDC2025-12-19
06946480584224Disposable Skin Staple Removers Sinolinks Medical Innovation Co., Ltd.KDC2025-09-04
00194613020576MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613043209MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613044381MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613044633MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613045296MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613045302MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613045531MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613047153MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613054250MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613054441MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613054472MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613054496MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613054571MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613054762MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613062163MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613088026MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613088101MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613088118MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613088132MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613088194MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613089672MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613089757MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613089764MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613090890MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613091330MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613091774MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613093228MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01