FDA UDI Not in Commercial Distribution 🇺🇸 United States

Dale Abdominal Binder

DI: H84108201 · Model: 820 · Dale Medical Products, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Dale Abdominal Binder
Primary DI
H84108201
Version / Model
820
Catalog Number
820
Company Name
Dale Medical Products, Inc.
Labeler DUNS
001061233
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-08-27
Public Version
5
Public Version Date
2024-04-23
Public Version Status
Update
Public Device Record Key
ca692f37-b3c3-47d8-9d39-c851fa250146
Distribution End Date
2019-06-24

Device Description

Dale Abdominal Binder, 12" wide, stretches to fit 72"-94", 1 per box.

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
FSD Binder, Abdominal

GMDN Terms

Code Name
10003 Abdominal binder, single-use

Identifiers

Type ID
Primary H84108201