FDA UDI
In Commercial Distribution
🇺🇸 United States
ATRAMAT
DI: 07500142016899
·
Model: PGC25
·
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
- 07500142016899
- Version / Model
- PGC25
- Catalog Number
- SGH2603
- 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
- 2018-07-11
- Public Version
- 1
- Public Version Date
- 2018-08-13
- Public Version Status
- New
- Public Device Record Key
- fab2b971-16b6-4f6a-a5cf-35b9a46bd36b
- Distribution End Date
- 2040-12-31
Device Description
ATRAMAT PGC25 SURGICAL SUTURE VIOLET USP 3-0 EP 2, 70 CM NEEDLE SGH-26 PREMIUM HEAVY TAPER POINT 26 MM 5/8 CIRCLE PGC25 VIOLETA USP 3-0, 70 CM AGUJA SGH-26 AHUSADA GRUESA PREMIUM 26 MM 5/8 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
- 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 |
|---|---|---|---|---|
| 45814 | Poliglecaprone suture | A sterile, single-strand (monofilament), synthetic, bioabsorbable thread made of poliglecaprone (a copolymer of glycolide and E-caprolactone of low tissue reactivity) 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. 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 | 07500142116896 | GS1 | DOZEN | 12 | In Commercial Distribution | 2040-12-31 |
| Primary | 07500142016899 | GS1 |
Customer Contacts
- Phone
- +525511050260
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K072863 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 26 | Millimeter | |
| Device Size Text, specify | 5/8 CIRCLE | ||
| Device Size Text, specify | SUTURE VIOLET | ||
| Device Size Text, specify | ATRAMAT PGC25 | ||
| 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