FDA UDI
In Commercial Distribution
🇺🇸 United States
Polycryl
DI: 00803878029032
·
Model: A6409
·
AUROLAB
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Polycryl
- Primary DI
- 00803878029032
- Version / Model
- A6409
- Company Name
- AUROLAB
- Labeler DUNS
- 677319965
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-12
- Public Version
- 2
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 48792361-d38b-480c-8d94-2a290643efa3
Device Description
Absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and PGA suture. A6409 model consists of a 6/0 PGA suture of length 45cm attached with two 510 microns SS needles having the needle length of 20.0mm in one end of suture. Angle of curvature of both the needles are 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 |
|---|---|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | 878.4493 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38000 | Nylon suture, non-bioabsorbable, monofilament | A single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) 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. The thread provides temporary wound support until the wound sufficiently heals. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10803878029039 | GS1 | Box | 12 | In Commercial Distribution | |
| Primary | 00803878029032 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140039 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 40 Degrees Celsius