FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Grasping Forceps 5mm O.D. (with Rubber Tips)
DI: 04953170154379
·
Model: T1079
·
OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Grasping Forceps 5mm O.D. (with Rubber Tips)
- Primary DI
- 04953170154379
- Version / Model
- T1079
- Company Name
- OLYMPUS MEDICAL SYSTEMS CORP.
- Labeler DUNS
- 711789789
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-08
- Public Version
- 7
- Public Version Date
- 2023-11-20
- Public Version Status
- Update
- Public Device Record Key
- 4968f3da-0d64-417d-a038-1ea4d1efbe17
- Distribution End Date
- 2022-08-19
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
- ["Ethylene Oxide", "Moist Heat or Steam Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCJ | Laparoscope, general & plastic surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65544 | Laparoscope manipulation forceps | A rigid manual device intended to allow grasping and manipulation of the distal end of an endoscope during a percutaneous endoscopic procedure; it is not intended for grasping of tissues. It is intended to be introduced through a separate percutaneous (laparoscopic) port/cannula for grasping and manoeuvring of the endoscope (e.g., into the biliary tract). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14953170154376 | GS1 | 1 | Not in Commercial Distribution | 2022-08-19 | |
| Primary | 04953170154379 | GS1 |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K944201 | 000 |