FDA UDI
In Commercial Distribution
🇺🇸 United States
COMFOR ARM SLING SM
DI: 00610570051335
·
Model: 90002102
·
Bird & Cronin, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- COMFOR ARM SLING SM
- Primary DI
- 00610570051335
- Version / Model
- 90002102
- Company Name
- Bird & Cronin, LLC
- Labeler DUNS
- 045975349
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-20
- Public Version
- 1
- Public Version Date
- 2022-08-29
- Public Version Status
- New
- Public Device Record Key
- cd3078d6-6706-4b60-82f3-1b31e88aaa2f
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- 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 |
|---|---|---|---|---|
| 46325 | Elevation arm sling | A non-sterile hanging band intended to immobilize an injured arm, that is typically suspended from an overhead support. It is designed to elevate the extremity to aid in controlling oedema, enhancing recovery typically following hand or forearm surgery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00610570051335 | GS1 |