FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: 00304040000397
·
Model: 900-4417
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Henry Schein
- Primary DI
- 00304040000397
- Version / Model
- 900-4417
- Catalog Number
- 900-4417
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-25
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- df9e0853-1f3d-4d3b-a0c3-1bb17834014b
Device Description
5-0 PGA UNDYED BRD 18"/45CM C3
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 | 20304040000391 | GS1 | 12 | In Commercial Distribution | ||
| Primary | 00304040000397 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- N/A