FDA UDI
In Commercial Distribution
🇺🇸 United States
ATRAMAT
DI: 07500142080197
·
Model: POLIESTER
·
Internacional Farmacéutica, S.A. de C.V.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ATRAMAT
- Primary DI
- 07500142080197
- Version / Model
- POLIESTER
- Catalog Number
- CVY1755/2-75
- Company Name
- Internacional Farmacéutica, S.A. de C.V.
- Labeler DUNS
- 811313428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-27
- Public Version
- 3
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 29b3d6a2-5eef-43a1-966c-8d15af66cb91
- Distribution End Date
- 2040-12-31
Device Description
ATRAMAT POLYESTER SURGICAL SUTURE GREEN USP 5-0 EP 1, 75 CM DOUBLE NEEDLE CVY-17 CARDIOVASCULAR PREMIUM TAPER CUTTING 17 MM 1/2 CIRCLE POLIESTER USP 5-0, 75 CM DOBLE AGUJA CVY-17 CARDIOVASCULAR AHUSADA PUNTA CORTANTE PREMIUM 17 MM 1/2 CIRCULO
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| GAS | Suture, Nonabsorbable, Synthetic, Polyester | General, Plastic Surgery | 878.5000 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13906 | Polyester suture, non-bioabsorbable, multifilament | A multiple-strand (multifilament), synthetic thread made from a non-bioabsorbable polyester 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 to withstand normal stress. 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 | 07500142180194 | GS1 | DOZEN | 12 | In Commercial Distribution | 2040-12-31 |
| Primary | 07500142080197 | GS1 |
Customer Contacts
- Phone
- +525511050260
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K905285 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 17 | Millimeter | |
| Device Size Text, specify | 1/2 CIRCLE | ||
| Device Size Text, specify | SUTURE GREEN | ||
| Device Size Text, specify | ATRAMAT POLYESTER | ||
| Device Size Text, specify | USP 5-0 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 65 Percent (%) Relative Humidity