FDA UDI
In Commercial Distribution
🇺🇸 United States
DemeSORB
DI: 10652927185239
·
Model: PGA176013F13M
·
DEMETECH CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- DemeSORB
- Primary DI
- 10652927185239
- Version / Model
- PGA176013F13M
- Company Name
- DEMETECH CORPORATION
- Labeler DUNS
- 039436691
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-20
- Public Version
- 4
- Public Version Date
- 2019-06-14
- Public Version Status
- Update
- Public Device Record Key
- b7dbbc86-d2e3-405d-ad29-1cdb5d265334
Device Description
Absorbable, Synthetic, Polyglycolic acid Suture
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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|---|---|
| Package | 30652927185233 | GS1 | 12 | In Commercial Distribution | ||
| Primary | 10652927185239 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K043539 | 000 |