FDA UDI
In Commercial Distribution
🇺🇸 United States
FILASILK
DI: 08904255209770
·
Model: SLK201588Z
·
MERIL ENDO SURGERY PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
36
Basic Information
- Brand Name
- FILASILK
- Primary DI
- 08904255209770
- Version / Model
- SLK201588Z
- Catalog Number
- SLK201588Z
- Company Name
- MERIL ENDO SURGERY PRIVATE LIMITED
- Labeler DUNS
- 870914838
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 36
- Record Status
- Published
- Publish Date
- 2019-03-06
- Public Version
- 2
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 109e8a6c-f123-4318-a7bd-e0cc04e8ad83
Device Description
BRAIDED COATED SILK BLACK
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| GAP | Suture, Nonabsorbable, Silk | General, Plastic Surgery | 878.5030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13910 | Silk suture | A natural, non-bioabsorbable thread made from raw silk spun by silkworms (typically coated with beeswax or silicone) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a "non-bioabsorbable" material, it may be digested by proteolysis after an extended period of time. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08904255209770 | GS1 | ||||
| Unit of Use | 18904255209777 | GS1 |
Customer Contacts
- Phone
- +1(609)9512287
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172149 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store below 25 °C