FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Instrument Stringers
DI: 00849771013280
·
Model: IS-55506
·
KEY SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Instrument Stringers
- Primary DI
- 00849771013280
- Version / Model
- IS-55506
- Catalog Number
- IS55506
- Company Name
- KEY SURGICAL, INC.
- Labeler DUNS
- 604056226
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-16
- Public Version
- 4
- Public Version Date
- 2023-04-05
- Public Version Status
- Update
- Public Device Record Key
- 3f0a3959-29a3-4c9f-972e-684f7b64f9fe
- Distribution End Date
- 2023-04-04
Device Description
U-Shaped Instrument Stringer, 6-inch x 5.5-inch
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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Moist Heat or Steam Sterilization", "Ethylene Oxide"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64168 | Sterilization stringer | A device designed to hang hinged, ring-handled surgical instruments (e.g. forceps, scissors) in an open position during sterilization. Often referred to as an instrument stringer, it is typically in the form of a U-/D-shaped locking bar. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00849771013280 | GS1 |
Customer Contacts
- Phone
- +1(800)541-7995
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 5.5 | Inch |