FDA UDI
In Commercial Distribution
🇺🇸 United States
CHALLENGER TI
DI: 04038653208463
·
Model: PL522R
·
Aesculap AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CHALLENGER TI
- Primary DI
- 04038653208463
- Version / Model
- PL522R
- Catalog Number
- PL522R
- Company Name
- Aesculap AG
- Labeler DUNS
- 315018218
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-20
- Public Version
- 1
- Public Version Date
- 2020-05-28
- Public Version Status
- New
- Public Device Record Key
- e07cab31-1d7c-47c2-8973-e3f687b0a812
Device Description
CHALLENGER TI Clip Applier (Shaft Only), multi-fire, (310 mm), diam. 5 mm, to be used with: PL510R, PL572T
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| GDO | Applier, surgical, clip | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35798 | Open-surgery ligation clip applier | A hand-held manual surgical instrument designed to apply small atraumatic clips (not included) for the ligation of blood vessels, or similar tubular anatomy, mainly to prevent and/or stop bleeding (i.e., haemostasis) during an open-surgery procedure. It may also be used to apply small clamps (e.g., bulldog type) to tissues however it is not intended to apply an aneurysm clip. The device is typically a metallic instrument with flat, curved ends to hold and deliver the clips (e.g., forceps-like); implantable clips are not included. This is a reusable device after sterilization. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04038653208463 | GS1 |
Customer Contacts
- Phone
- +1(800)282-9000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Diameter (mm) : 5.000 MM | ||
| Device Size Text, specify | Length : 310.000 MM |