FDA UDI
In Commercial Distribution
🇺🇸 United States
RePlay
DI: 00816734021484
·
Model: 1170-01
·
DIVERSATEK HEALTHCARE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- RePlay
- Primary DI
- 00816734021484
- Version / Model
- 1170-01
- Catalog Number
- 1170-01
- Company Name
- DIVERSATEK HEALTHCARE, INC.
- Labeler DUNS
- 030650113
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-01
- Public Version
- 3
- Public Version Date
- 2019-03-22
- Public Version Status
- Update
- Public Device Record Key
- d750cfec-2ec3-4c03-aa05-44d4db217385
Device Description
RePlay Hemostasis Clip, 11mm span
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
- Yes
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| PKL | Hemostatic Metal Clip For The Gi Tract | Gastroenterology, Urology | 876.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61207 | Gastrointestinal endoscopic clip, short-term | A sterile clip intended to be placed short-term (<=30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and/or for treating mucosal/submucosal defects. It is a metallic device with a clasping mechanism; a disposable applicator may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10816734021481 | GS1 | case | 5 | In Commercial Distribution | |
| Primary | 00816734021484 | GS1 |
Customer Contacts
- Phone
- 800-558-6408
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 230 | Centimeter | |
| Outer Diameter | 2.3 | Millimeter | |
| Width | 11 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 86 – 106 KiloPascal