FDA UDI
Not in Commercial Distribution
🇺🇸 United States
PERLA ®
DI: 07640151095406
·
Model: CPF-IN 34 00-N
·
SpineArt SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PERLA ®
- Primary DI
- 07640151095406
- Version / Model
- CPF-IN 34 00-N
- Catalog Number
- CPF-IN 34 00-N
- Company Name
- SpineArt SA
- Labeler DUNS
- 483016148
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-14
- Public Version
- 5
- Public Version Date
- 2019-02-06
- Public Version Status
- Update
- Public Device Record Key
- f72a6eac-1a2d-4a49-b160-41d57885ec79
- Distribution End Date
- 2019-02-05
Device Description
Rod gripper
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | 888.3050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62591 | Implant handling forceps, alligator | A hand-held manual surgical instrument with blades designed to grasp and manipulate surgical implants/devices (excluding sutures) during implantation; it is not intended for use on soft tissues, not an ophthalmic device, and is not a dedicated tissue clip applier. It is shaped like alligator- or crocodile-forceps, having a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is made of high-grade stainless steel and is available in various sizes. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640151095406 | GS1 |