FDA UDI
In Commercial Distribution
🇺🇸 United States
Olympus
DI: 00821925038875
·
Model: PK-AI2055
·
Gyrus ACMI, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Olympus
- Primary DI
- 00821925038875
- Version / Model
- PK-AI2055
- Company Name
- Gyrus ACMI, LLC
- Labeler DUNS
- 007198742
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-26
- Public Version
- 1
- Public Version Date
- 2024-12-04
- Public Version Status
- New
- Public Device Record Key
- 9ddf3a0b-cbe4-48ce-a4d1-54b0c8bf582d
Device Description
PK ADVANCED INTERGRATED MULTIFUNCTIONAL DEVICE (5/PK, For use with ESG 400 Generator Only)
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
- 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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38711 | Flexible endoscopic biopsy forceps, single-use | A flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy, laryngoscopy) for histopathological examination. It is typically a flexible metal coil with a pair of scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00821925038868 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00821925038875 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -29 – 50 Degrees Fahrenheit