FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SOFTCAT
DI: 04046964840326
·
Model: B0664436
·
B BRAUN SURGICAL SA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
24
Basic Information
- Brand Name
- SOFTCAT
- Primary DI
- 04046964840326
- Version / Model
- B0664436
- Catalog Number
- B0664436
- Company Name
- B BRAUN SURGICAL SA
- Labeler DUNS
- 511268005
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 24
- Record Status
- Published
- Publish Date
- 2018-05-03
- Public Version
- 3
- Public Version Date
- 2021-10-13
- Public Version Status
- Update
- Public Device Record Key
- 754a34b5-08a1-4f14-a858-410afd8526b6
- Distribution End Date
- 2021-10-12
Device Description
SOFTCAT CHROM 2 (6)120CM HS30 NCE DDP
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 |
|---|---|---|---|---|
| GAL | SUTURE, ABSORBABLE, NATURAL | General, Plastic Surgery | 878.4830 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45025 | Catgut suture, chromic | A single-strand (monofilament), natural, bioabsorbable thread composed mostly of collagen fibres derived from mammals (e.g., sheep or bovine intestines), impregnated with chromium salts to increase tensile strength and retard absorption, intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by enzymatic degradation. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046964840326 | GS1 | ||||
| Unit of Use | 04046964840319 | GS1 |
Customer Contacts
- Phone
- +1(800)282-9000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Thread Material : collagen | ||
| Length | 120.0 | Centimeter | |
| Device Size Text, specify | Size of Thread (USP - Others) : 2 |