FDA UDI
In Commercial Distribution
🇺🇸 United States
Oasis
DI: B031MVJ4680
·
Model: MV-J468
·
American Health Service Sales Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Oasis
- Primary DI
- B031MVJ4680
- Version / Model
- MV-J468
- Company Name
- American Health Service Sales Corporation
- Labeler DUNS
- 556115970
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-01-14
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 8c3e1bbc-a80e-417b-b53c-d2c60ba6f3ef
Device Description
SUTURE,PGA,1,NCP-1
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
- 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 |
|---|---|---|---|---|---|---|
| Primary | B031MVJ4680 | HIBCC | ||||
| Package | B031MVJ4681 | HIBCC | 12 | In Commercial Distribution | ||
| Package | B031MVJ4682 | HIBCC | 100 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K073614 | 000 |