FDA.reportPublic FDA data

Dale Abdominal Binder

Primary DI
00817612020384
Brand
Dale Abdominal Binder
Company
Dale Medical Products, Inc.
Model
418
Catalog number
418
Device description
"Dale Abdominal Binder, 9"" wide, stretches to fit 60""-75"", 1 per box."
Published
2019-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
FSDBinder, Abdominal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSDBinder, AbdominalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H84104181PreviousHIBCC0
00817612020384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817612020384008176120203848176120203840817612020384

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal binder, single-useA strip, roll or tube of fabric or polymer material intended to be applied to the abdomen to support relaxed abdominal walls (e.g., after surgery, during pregnancy) or to provide support for another device (e.g., dressing, ultrasound transducer, percutaneous lead). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Cool Dry Place

Regulatory Flags#

DUNS number
001061233
Device count
1
Premarket exempt
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
H84101501Dale Foley Catheter Holder1501502018-08-30
H84103161Dale Foley Catheter Holder3163162018-08-30
H84103301Dale Foley Catheter Holder3303302018-08-30
H84104901Dale Urodynamic Tube Holder4904902018-08-30
00817612020001Dale General Purpose Securement Device9529522018-09-10
00817612020025Dale Catheter Securement Device8538532018-09-10
00817612020124Dale Catheter Securement Device8508502018-09-10
00817612020148Dale Catheter Securement Device8518512018-09-10
00817612020162Dale Catheter Securement Device8528522018-09-10
00817612020186Dale Catheter Securement Device8548542018-09-10
00817612020209Dale General Purpose Securement Device9509502018-09-10
00817612020223Dale General Purpose Securement Device9519512018-09-10
00817612020902Dale Catheter Securement Device8498492018-09-10
00817612020926Dale Catheter Securement Device8488482018-10-10
00817612021107Dale IV Line Manager6306302025-08-11
00817612020544Dale Foley Catheter Holder1501502019-03-18
00817612020568Dale Foley Catheter Holder3163162019-03-18
00817612020582Dale Foley Catheter Holder3303302019-03-18
00817612021121Dale Airway Holder2602602026-03-11
00817612021114Dale IV Line Manager6306302025-08-11

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