FDA.report

DeRoyal

Primary DI
00749756635301
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
68-106
Catalog number
68-106
Device description
O.R Towel, X-Ray Detectable
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

Related Records

Contact Domains

Product Codes

CodeName
FRLFIBER, MEDICAL, ABSORBENT

Product Code Classifications

CodeDeviceSpecialtyClass
FRLFiber, Medical, AbsorbentGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00749756635301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00749756635301007497566353017497566353010749756635301

GMDN Terms

TermDefinition
Surgical towelA sterile cloth used in the operating room (OR) to absorb extraneous fluids. 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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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50749756401451DeRoyalM70-200CNWM70-200CNW2026-01-01
50749756401468DeRoyalM70-200PNWM70-200PNW2026-01-01
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00749756399340DeRoyal1-524A-02-CHO1-524A-02-CHO2025-07-30
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