FDA.report

DeRoyal

Primary DI
00749756112970
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
M5001-S
Catalog number
M5001-S
Device description
SURGICAL BRA
Published
2021-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FSDBINDER, ABDOMINAL

Product Code Classifications

CodeDeviceSpecialtyClass
FSDBinder, AbdominalGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00749756112970PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00749756112970007497561129707497561129700749756112970

GMDN Terms

TermDefinition
Postsurgical brassiere, non-antimicrobialA woman's undergarment designed to support and/or contour the breast(s) after surgical intervention (e.g., thoracic surgery, mastectomy, lumpectomy); it may also be intended for use during medical treatment (e.g., chemotherapy). It may also be referred to as bra, and is specifically designed for patient support/comfort in the home or healthcare facility; it does not include antimicrobial features. This is a reusable 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

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