FDA UDI
Not in Commercial Distribution
🇺🇸 United States
E.M Adams co, inc.
DI: 18100013405744
·
Model: EP12-1707M-1
·
E.M. ADAMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- E.M Adams co, inc.
- Primary DI
- 18100013405744
- Version / Model
- EP12-1707M-1
- Company Name
- E.M. ADAMS, INC.
- Labeler DUNS
- 001403807
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-31
- Public Version
- 3
- Public Version Date
- 2021-03-01
- Public Version Status
- Update
- Public Device Record Key
- ed047e35-4dbd-463e-b735-ad9bb6a7789c
- Distribution End Date
- 2021-02-28
Device Description
ARM SLING
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- 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 |
|---|---|---|---|---|
| ILI | Sling, Arm | Physical Medicine | 890.3640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13622 | Suspension arm sling | A non-sterile hanging triangular-shaped loop, suspended from a patient's neck/shoulder, typically intended to support an injured arm and limit its range of motion, or immobilize it, during the period of healing. It is typically fashioned from a single sheet of textile material by tying/fastening the ends. This is a reusable device intended for single-patient use. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 58100013405735 | GS1 | Case | 6 | Not in Commercial Distribution | 2021-02-28 |
| Primary | 18100013405744 | GS1 |
Customer Contacts
- Phone
- +1(772)461-0532
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | MEDIUM SLING/1" X 40" STRAP |