FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SUSI
DI: 04046963892777
·
Model: BH197SU
·
Aesculap AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
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Basic Information
- Brand Name
- SUSI
- Primary DI
- 04046963892777
- Version / Model
- BH197SU
- Catalog Number
- BH197SU
- Company Name
- Aesculap AG
- Labeler DUNS
- 315018218
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2020-04-24
- Public Version
- 2
- Public Version Date
- 2022-04-15
- Public Version Status
- Update
- Public Device Record Key
- 674fc429-e6f4-4326-99b1-4b58f4c74d4d
- Distribution End Date
- 2022-04-12
Device Description
BIRKETT SUSI Hemostatic Forceps, curved, 7 1/4", (185 mm), sterile, disposable, pack of 20 pcs, single packed
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
- Yes
- 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 |
|---|---|---|---|---|
| GEN | FORCEPS, GENERAL & PLASTIC SURGERY | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61478 | Surgical soft-tissue manipulation forceps, scissors-like, single-use | A hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues; it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 04038653331338 | GS1 | ||||
| Primary | 04046963892777 | GS1 |
Customer Contacts
- Phone
- +1(800)282-9000
- [email protected]