FDA UDI
In Commercial Distribution
🇺🇸 United States
ATRAMAT
DI: 07500142003103
·
Model: PGA
·
Internacional Farmacéutica, S.A. de C.V.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- ATRAMAT
- Primary DI
- 07500142003103
- Version / Model
- PGA
- Catalog Number
- U6093-B
- 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
- 2018-07-06
- Public Version
- 1
- Public Version Date
- 2018-08-06
- Public Version Status
- New
- Public Device Record Key
- e46ae314-682d-4394-bf6b-621aba4df84e
- Distribution End Date
- 2040-12-31
Device Description
ATRAMAT PGA SURGICAL SUTURE UNDYED USP 3-0 EP 2, 70 CM NEEDLE U-60 STRAIGHT CUTTING 60 MM STRAIGHT PGA INCOLORO USP 3-0, 70 CM AGUJA U-60 RECTA CORTANTE 60 MM RECTA
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 |
|---|---|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | 878.4493 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13908 | Polyglycolic acid suture | A sterile, typically multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) that is intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. It may include an attached needle intended to be disposed of after single use; it may be coated with a material such as polycaprolactone or uncoated. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07500142103100 | GS1 | DOZEN | 12 | In Commercial Distribution | 2040-12-31 |
| Primary | 07500142003103 | GS1 |
Customer Contacts
- Phone
- +525511050260
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K040282 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | WITHOUT NEEDLE | ||
| Device Size Text, specify | SUTURE VIOLET | ||
| Device Size Text, specify | ATRAMAT PGA | ||
| Device Size Text, specify | USP 3-0 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 65 Percent (%) Relative Humidity