FDA UDI
In Commercial Distribution
🇺🇸 United States
Clip applying forceps
DI: 04059082015729
·
Model: 392 999 800
·
SOPRO-COMEG GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Clip applying forceps
- Primary DI
- 04059082015729
- Version / Model
- 392 999 800
- Company Name
- SOPRO-COMEG GmbH
- Labeler DUNS
- 507185952
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-12
- Public Version
- 4
- Public Version Date
- 2019-08-21
- Public Version Status
- Update
- Public Device Record Key
- c18106b8-8ea3-4ef8-90ab-dbee0dae2eac
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| 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 | 04059082015729 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K945266 | 000 |