FDA UDI
In Commercial Distribution
🇺🇸 United States
Saberscope
DI: 00854490007038
·
Model: XSA-0-0536
·
XENOCOR, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Saberscope
- Primary DI
- 00854490007038
- Version / Model
- XSA-0-0536
- Catalog Number
- XSA-0-0536
- Company Name
- XENOCOR, INC.
- Labeler DUNS
- 080306345
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-17
- Public Version
- 2
- Public Version Date
- 2025-03-06
- Public Version Status
- Update
- Public Device Record Key
- 9c920c72-5389-4d61-81f3-2e61b0137699
Device Description
5 mm Articulating Laparoscope
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
- 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 |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
| GCQ | Endoscope, Flexible | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36283 | Flexible-tip video laparoscope | An electronic endoscope with a flexible distal tip intended for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. It is inserted through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy. Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor. The abdominal wall is distended providing space to allow the surgeon to directly view and/or operate on the exposed organs. It is used to evaluate/treat abdominal or pelvic pain, ectopic pregnancy, and ovarian cysts. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00854490007038 | GS1 |