FDA UDI
In Commercial Distribution
🇺🇸 United States
XS
DI: 04038653261925
·
Model: FM720R
·
Aesculap AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- XS
- Primary DI
- 04038653261925
- Version / Model
- FM720R
- Catalog Number
- FM720R
- Company Name
- Aesculap AG
- Labeler DUNS
- 315018218
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-23
- Public Version
- 3
- Public Version Date
- 2022-11-24
- Public Version Status
- Update
- Public Device Record Key
- 23cb4afd-60fe-451c-bd29-36f9b47da76c
Device Description
PERNECZKY/CRISTANTE XS Tumor Forceps, 8", (200 mm), working length: 2 3/4", (70 mm), diam. 3 mm, bayonet-shaped, sharp/sharp, consisting of FM725R, FM730R
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 |
|---|---|---|---|---|
| HTD | FORCEPS | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62466 | Surgical soft-tissue manipulation forceps, tweezers-like, reusable | A hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04038653261925 | GS1 |
Customer Contacts
- Phone
- +1(800)282-9000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Diameter (mm) : 3.000 MM | ||
| Device Size Text, specify | Length : 200.000 MM | ||
| Device Size Text, specify | Working length (mm) : 70.000 MM |