FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ENDO-SPIKE
DI: 04055207049150
·
Model: 491403000
·
Richard Wolf GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- ENDO-SPIKE
- Primary DI
- 04055207049150
- Version / Model
- 491403000
- Catalog Number
- 491403000
- Company Name
- Richard Wolf GmbH
- Labeler DUNS
- 315304071
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2022-11-01
- Public Version
- 2
- Public Version Date
- 2023-09-22
- Public Version Status
- Update
- Public Device Record Key
- d2ce969b-d376-4902-aed3-b14edaa199ae
- Distribution End Date
- 2023-09-14
Device Description
NEEDLES FOR STITCHING FORCEPS for ENDO-SPIKE 891403000, PACK = 5 PCS, sterile, for single use
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NBH | Accessories, arthroscopic | Orthopedic | 888.1100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38825 | General-purpose endoscopic needle, single-use | A flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 04055207050279 | GS1 | ||||
| Primary | 04055207049150 | GS1 |
Customer Contacts
- Phone
- +497043350
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 70 Percent (%) Relative Humidity