FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Dale Post Surgical Bra
DI: H84107061
·
Model: 706
·
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 Post Surgical Bra
- Primary DI
- H84107061
- Version / Model
- 706
- Catalog Number
- 706
- 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
- 8
- Public Version Date
- 2024-04-23
- Public Version Status
- Update
- Public Device Record Key
- a85f28a4-ff16-4e22-b5c3-5b485f34191e
- Distribution End Date
- 2019-06-24
Device Description
Dale Post Surgical Bra, XXX-Large, fits E-I, 54"-60", 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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HEF | Binder, Breast | General Hospital | 880.5160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10481 | Postsurgical brassiere, non-antimicrobial | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | H84107061 | HIBCC |