FDA UDI
In Commercial Distribution
🇺🇸 United States
Large Right Arm Anchor
DI: 00858101008353
·
Model: K813
·
RIFTON EQUIPMENT
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Large Right Arm Anchor
- Primary DI
- 00858101008353
- Version / Model
- K813
- Company Name
- RIFTON EQUIPMENT
- Labeler DUNS
- 808251438
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-16
- Public Version
- 1
- Public Version Date
- 2022-09-26
- Public Version Status
- New
- Public Device Record Key
- ae3b8241-980b-4898-91ee-caeebb845f1f
Device Description
Arm Anchor
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| KID | Restraint, Wheelchair, Non-Protective | Physical Medicine | 890.3910 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63665 | Assistive suction cup stabilizer/hand-hold | A manual device designed to assist a patient with a disability to maintain upper-body stability/control by temporary fixation to a horizontal surface. It consists of one or more suction cup(s) with variously-shaped attached handles, and/or straps, for the patient to hold on to and/or be attached to. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858101008353 | GS1 |