FDA UDI
In Commercial Distribution
🇺🇸 United States
ATRAMAT
DI: 07500142000904
·
Model: NYLON
·
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
- 07500142000904
- Version / Model
- NYLON
- Catalog Number
- CE2441-75N
- 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
- 2018-07-04
- Public Version
- 3
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 44f87040-76b3-4f11-8106-691f528edc9c
- Distribution End Date
- 2040-12-31
Device Description
ATRAMAT NYLON SURGICAL SUTURE BLACK USP 0 EP 3,5, 75 CM NEEDLE CE-24 REVERSE CUTTING 24 MM 3/8 CIRCLE NYLON NEGRO USP 0, 75 CM AGUJA CE-24 REVERSO CORTANTE 24 MM 3/8 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
- No
- 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 |
|---|---|---|---|---|
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | General, Plastic Surgery | 878.5020 | 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 | 07500142100901 | GS1 | DOZEN | 12 | In Commercial Distribution | 2040-12-31 |
| Primary | 07500142000904 | GS1 |
Customer Contacts
- Phone
- +525511050260
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K905286 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 24 | Millimeter | |
| Device Size Text, specify | 3/8 CIRCLE | ||
| Device Size Text, specify | SUTURE BLACK | ||
| Device Size Text, specify | ATRAMAT NYLON | ||
| Device Size Text, specify | USP 0 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 65 Percent (%) Relative Humidity