FDA Registration
Active
🇹🇷 Türkiye
K6-3412-CONTAINER SAFETY LID 3/4 STANDARD PLUS MODEL GREEN
Reg #: 3006113180
·
FEI: 3006113180
·
Expires 2025
Products
1
Proprietary Names
41
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- AYGUN SURGICAL INSTRUMENTS CO.,INC.
- Registration Number
- 3006113180
- FEI Number
- 3006113180
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ORGANIZE SANAYI BOLGESI
- City
- KUTLUKENT Samsun
- Country
- TR
Regulatory Submissions
- 510(k) Number
- K233222
Owner / Operator
- Firm Name
- AYGUN SURGICAL INSTRUMENTS CO.,INC.
- Operator Number
- 9089161
- Address
- ORGANIZE SANAYI BOLGESI
- City
- Kutlukent, Samsun
- State
- TR-55
- Postal Code
- 55330
- Country
- TR
- Correspondent
- Melike Yilmaz
US Agent
- Business Name
- Medes USA C/O Matan Arazy
- Contact Name
- Benny Arazy
- Address
- 15201 6th Ave NE, ,
- City
- Shoreline
- State
- WA
- ZIP
- 98155
- Country
- US
- [email protected]
- Phone
- 415 8024021
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2024-02-28 |
Proprietary Names
K6-3412-CONTAINER SAFETY LID 3/4 STANDARD PLUS MODEL GREEN
K2-571-IDENTIFICATION LABELWITHOUT CLIP - BLUE
K2-576-IDENTIFICATION LABELWITHOUT CLIP - PURPLE
K6-3414-CONTAINER SAFETY LID 3/4 STANDARD PLUS MODEL RED
K2-560-IDENTIFICATION LABEL WITH CLIP - RED
K2-577-IDENTIFICATION LABELWITHOUT CLIP - BRONZE
K6-3705-CONTAINER SAFETY LID 1/2 STANDARD PLUS MODEL BLACK
K6-3415-CONTAINER SAFETY LID 3/4 STANDARD PLUS MODEL BLACK
K6-3700-CONTAINER SAFETY LID 1/2 STANDARD PLUS MODEL GREY
K6-3236-CONTAINER SAFETY LID 1/1 STANDARD PLUS MODEL PURPLE
K6-3703-CONTAINER SAFETY LID 1/2 STANDARD PLUS MODEL BLUE
K6-3413-CONTAINER SAFETY LID 3/4 STANDARD PLUS MODEL BLUE
K6-3411-CONTAINER SAFETY LID 3/4 STANDARD PLUS MODEL YELLOW
K2-573-IDENTIFICATION LABELWITHOUT CLIP - YELLOW
K6-3707-CONTAINER SAFETY LID 1/2 STANDARD PLUS MODEL BRONZE
K6-3230-CONTAINER SAFETY LID 1/1 STANDARD PLUS MODEL GREY
K6-3416-CONTAINER SAFETY LID 3/4 STANDARD PLUS MODEL PURPLE
K2-574-IDENTIFICATION LABELWITHOUT CLIP - GREY
K6-3701-CONTAINER SAFETY LID 1/2 STANDARD PLUS MODEL YELLOW
K6-3702-CONTAINER SAFETY LID 1/2 STANDARD PLUS MODEL GREEN
K2-570-IDENTIFICATION LABELWITHOUT CLIP - RED
Aygun Sterilization Container Systems
K6-3704-CONTAINER SAFETY LID 1/2 STANDARD PLUS MODEL RED
K6-3231-CONTAINER SAFETY LID 1/1 STANDARD PLUS MODEL YELLOW
K6-3417-CONTAINER SAFETY LID 3/4 STANDARD PLUS MODEL BRONZE
K2-562-IDENTIFICATION LABEL WITH CLIP - GREEN
K6-3410-CONTAINER SAFETY LID 3/4 STANDARD PLUS MODEL GREY
K2-566-IDENTIFICATION LABEL WITH CLIP - PURPLE
K6-3234-CONTAINER SAFETY LID 1/1 STANDARD PLUS MODEL RED
K2-563-IDENTIFICATION LABEL WITH CLIP - YELLOW
K2-567-IDENTIFICATION LABEL WITH CLIP - BRONZE
K6-3235-CONTAINER SAFETY LID 1/1 STANDARD PLUS MODEL BLACK
K2-561-IDENTIFICATION LABEL WITH CLIP - BLUE
K2-564-IDENTIFICATION LABEL WITH CLIP - GREY
K6-3232-CONTAINER SAFETY LID 1/1 STANDARD PLUS MODEL GREEN
K2-565-IDENTIFICATION LABEL WITH CLIP - BLACK
K6-3233-CONTAINER SAFETY LID 1/1 STANDARD PLUS MODEL BLUE
K2-572-IDENTIFICATION LABELWITHOUT CLIP - GREEN
K6-3706-CONTAINER SAFETY LID 1/2 STANDARD PLUS MODEL PURPLE
K6-3237-CONTAINER SAFETY LID 1/1 STANDARD PLUS MODEL BRONZE
K2-575-IDENTIFICATION LABELWITHOUT CLIP - BLACK
Establishment Types
Manufacture Medical Device