FDA UDI
In Commercial Distribution
🇺🇸 United States
ISI
DI: 00810045921655
·
Model: Stainless Steel Finger Traps w/Ball Chain
·
INSTRUMENT SPECIALISTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ISI
- Primary DI
- 00810045921655
- Version / Model
- Stainless Steel Finger Traps w/Ball Chain
- Catalog Number
- K-3278-BC
- Company Name
- INSTRUMENT SPECIALISTS, INC.
- Labeler DUNS
- 041517095
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-30
- Public Version
- 1
- Public Version Date
- 2020-08-07
- Public Version Status
- New
- Public Device Record Key
- 30f238c5-7ac7-4156-8dc0-62378fc26194
Device Description
Extra Small SS Finger Trap with 10" Ball Chain
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ILZ | Accessories, Traction | Physical Medicine | 890.5925 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62639 | Upper-limb traction wrap/trap, reusable | A preformed device designed to encompass the fingers, hand or forearm to create a holder which can be attached to an external frame to provide traction/suspension of the upper limb during surgical procedures on the hand, arm or shoulder. It is typically made of metal or synthetic polymer materials (e.g., nylon) with self-retaining fasteners (e.g., Velcro), and may be used with a traction arm band and/or malleable metal stave which acts as the anchor to the traction frame; some types may be inflatable to provide grip by means of air pressure. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810045921655 | GS1 |