FDA UDI
In Commercial Distribution
🇺🇸 United States
Peel-Away
DI: 00827002144286
·
Model: G14428
·
COOK INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Peel-Away
- Primary DI
- 00827002144286
- Version / Model
- G14428
- Catalog Number
- 074010
- Company Name
- COOK INCORPORATED
- Labeler DUNS
- 042823948
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 9794b030-26fd-43a0-9b4d-5a5a08cfd919
Device Description
Peel-Away, Introducer Set
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KOE | DILATOR, URETHRAL | Gastroenterology, Urology | 876.5520 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56655 | Encapsulating-tissue dilation sheath | A sterile, hand-held, manual surgical instrument designed for the percutaneous dilation of tissue surrounding a device or object that has been previously placed or found within a patient's body (e.g., cardiac leads, indwelling catheter, foreign object). It is a single-lumen, catheter-like device (a sheath) with a long, slender, tubular body; its narrow distal tip typically includes radiopaque markers to enable fluoroscopic identification of tip location and orientation. It is typically made of stainless steel and is available in various lengths and diameters. It may also be used for the introduction and support of intravascular catheters. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00827002144286 | GS1 |
Customer Contacts
- Phone
- +1(812)330-5494
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in dark, dry, cool place.