FDA UDI
In Commercial Distribution
🇺🇸 United States
Aurosilk
DI: 00803878029070
·
Model: B4401
·
AUROLAB
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Aurosilk
- Primary DI
- 00803878029070
- Version / Model
- B4401
- Company Name
- AUROLAB
- Labeler DUNS
- 677319965
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-23
- Public Version
- 2
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- d1270ca3-829a-4bd4-8f91-105154daf7a1
Device Description
Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and Braided Silk suture. B4401 model consists of a 4/0 Braided Silk suture of length 76cm attached with one 430 microns SS needles having the needle length of 15.9mm in both ends of suture. Angle of curvature of the needle is 135° [3/8 Circle]. Point profile of needle is Conventional cutting.
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|---|---|
| Package | 10803878029077 | GS1 | Box | 12 | In Commercial Distribution | |
| Primary | 00803878029070 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K024091 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 40 Degrees Celsius