FDA UDI
In Commercial Distribution
🇺🇸 United States
MEGASORB
DI: 18904255209906
·
Model: PGA305638UZ
·
MERIL ENDO SURGERY PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
36
Basic Information
- Brand Name
- MEGASORB
- Primary DI
- 18904255209906
- Version / Model
- PGA305638UZ
- Catalog Number
- PGA305638UZ
- Company Name
- MERIL ENDO SURGERY PRIVATE LIMITED
- Labeler DUNS
- 870914838
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 36
- Record Status
- Published
- Publish Date
- 2018-10-04
- Public Version
- 1
- Public Version Date
- 2018-11-05
- Public Version Status
- New
- Public Device Record Key
- 1aa03a4a-5f3c-48fd-9d37-817875a622e0
Device Description
Braided coated Polyglycolic Acid Surgical Suture USP
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|---|---|
| Primary | 18904255209906 | GS1 | ||||
| Unit of Use | 08904255209909 | GS1 |
Customer Contacts
- Phone
- +1(609)9512287
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172659 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store below 25 °C