FDA UDI
In Commercial Distribution
🇺🇸 United States
Steelex
DI: 04045439016747
·
Model: G0617802
·
B BRAUN SURGICAL SA
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
Basic Information
- Brand Name
- Steelex
- Primary DI
- 04045439016747
- Version / Model
- G0617802
- Catalog Number
- G0617802
- Company Name
- B BRAUN SURGICAL SA
- Labeler DUNS
- 511268005
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2015-08-20
- Public Version
- 7
- Public Version Date
- 2021-10-19
- Public Version Status
- Update
- Public Device Record Key
- 64fa6335-e667-42c8-b3c7-a1bba7c57b07
Device Description
STEELEX STE SET 7 (9) 4X75CM HRN48 LPCE
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
- Yes
- 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 |
|---|---|---|---|---|
| PTX | Suture, nonabsorbable, steel, monofilament and multifilament, sterile, exempt | General, Plastic Surgery | 878.4495 | 2 |
| 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 |
|---|---|---|---|---|---|---|
| Primary | 04045439016747 | GS1 | ||||
| Unit of Use | 04046963056780 | GS1 |
Customer Contacts
- Phone
- +1(800)282-9000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Size of Thread (USP - Others) : 7 | ||
| Length | 75 | Centimeter | |
| Device Size Text, specify | Thread Material : stainless steel |