Dale Post Surgical Compression Bra 715

GUDID 00817612021084

Dale Post Surgical Compression Bra, XX-Large, fits C-E, 46"-54", 1 per box.

Dale Medical Products, Inc.

Postsurgical brassiere, non-antimicrobial
Primary Device ID00817612021084
NIH Device Record Key3b0d1191-9993-49a3-a316-02809055ab17
Commercial Distribution StatusIn Commercial Distribution
Brand NameDale Post Surgical Compression Bra
Version Model Number715
Catalog Number715
Company DUNS001061233
Company NameDale Medical Products, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Cool Dry Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool Dry Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool Dry Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool Dry Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool Dry Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool Dry Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool Dry Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool Dry Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool Dry Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool Dry Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool Dry Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool Dry Place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool Dry Place

Device Identifiers

Device Issuing AgencyDevice ID
GS100817612021084 [Primary]

FDA Product Code

HEFBinder, Breast

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-08
Device Publish Date2025-03-31

On-Brand Devices [Dale Post Surgical Compression Bra]

00817612021091Dale Post Surgical Compression Bra, XXX-Large, fits E-I, 54"-60", 1 per box.
00817612021084Dale Post Surgical Compression Bra, XX-Large, fits C-E, 46"-54", 1 per box.
00817612021077Dale Post Surgical Compression Bra, X-Large, fits B-D, 38"-44", 1 per box.
00817612021060Dale Post Surgical Compression Bra, Large, fits B-D, 36"-38", 1 per box.
00817612021053Dale Post Surgical Compression Bra, Medium, fits B-D, 34"-36", 1 per box.

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