FDA UDI
In Commercial Distribution
🇺🇸 United States
Cravat
DI: M68932600040
·
Model: 04
·
Safeguard US Operating, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cravat
- Primary DI
- M68932600040
- Version / Model
- 04
- Catalog Number
- 32-600
- Company Name
- Safeguard US Operating, LLC
- Labeler DUNS
- 118492643
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-11
- Public Version
- 2
- Public Version Date
- 2022-04-12
- Public Version Status
- Update
- Public Device Record Key
- 7c86cac1-4f07-4e7f-8fc8-9fdc44e4eda5
Device Description
CRAVAT 1 ea - 37"x52" triangle bandage, 2 ea - safety pins
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
- 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
- No
- 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 |
|---|---|---|---|---|---|---|
| Primary | M68932600040 | HIBCC |