FDA UDI
In Commercial Distribution
🇺🇸 United States
Shoulder Brace with Airplane Kit LOGO
DI: 00810113683034
·
Model: OSAK3-PL
·
Manamed, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Shoulder Brace with Airplane Kit LOGO
- Primary DI
- 00810113683034
- Version / Model
- OSAK3-PL
- Catalog Number
- OSAK3-PL
- Company Name
- Manamed, Inc.
- Labeler DUNS
- 084042331
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-19
- Public Version
- 1
- Public Version Date
- 2025-09-29
- Public Version Status
- New
- Public Device Record Key
- e9049d55-a831-49d8-8429-f0ea803440a2
Device Description
The Shoulder Brace with Airplane Kit provides support for shoulder surgeries in a universal multiple configuration brace. Suitable for all shoulder surgeries as well as conservative care of shoulder injuries. The Shoulder Brace with Airplane Kit is your new go to shoulder brace for all your clinical needs. Sized universal Low-profile design True Airplane or Gunslinger alignment Two step application Multiple abduction angles Extreme external rotation
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| ILI | Sling, Arm | Physical Medicine | 890.3640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12101 | Shoulder immobilizer/orthosis, reusable | A prefabricated (non-customized) non-rigid wearable device designed to support, align, and/or temporarily immobilize the shoulder joint to support the healing of an injury or surgical wound. It will typically consist of straps, buckles, fasteners, or be in the form of a sling. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810113683034 | GS1 |
Customer Contacts
- Phone
- 800-233-6263
- [email protected]