FDA UDI
In Commercial Distribution
🇺🇸 United States
FSSB
DI: 00848782046331
·
Model: ST022R 4
·
Surgical Specialties México, S. de R.L. de C.V.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- FSSB
- Primary DI
- 00848782046331
- Version / Model
- ST022R 4
- Company Name
- Surgical Specialties México, S. de R.L. de C.V.
- Labeler DUNS
- 812762226
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-27
- Public Version
- 3
- Public Version Date
- 2024-11-11
- Public Version Status
- Update
- Public Device Record Key
- b12bc33f-a11f-4e25-8be9-f30fcf6b6a93
Device Description
FBRR-48-98-160P USP 7 Steel wire 12x4x45cm sterile 5.5 Wrapped
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
- Yes
- 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 |
|---|---|---|---|---|
| GAQ | Suture, nonabsorbable, steel, monofilament and multifilament, sterile | General, Plastic Surgery | 878.4495 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15971 | Metallic suture, monofilament | A single-strand (monofilament), non-bioabsorbable wire made of metal (e.g., surgical steel, titanium) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching (e.g., for abdominal wound closure, intestinal anastomosis, hernia repair), or transosseous (through bone) stitching (e.g., sternal closure); it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It is used primarily in orthopaedic, neurosurgical, and thoracic applications and provides temporary wound support until the wound sufficiently heals to withstand normal stress; it may be retained for permanent support. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10848782046338 | GS1 | Box | 12 | In Commercial Distribution | |
| Primary | 00848782046331 | GS1 |
Customer Contacts
- Phone
- +1(877)991-1110
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 12x4x45cm |