FDA UDI
In Commercial Distribution
🇺🇸 United States
HAVEL'S
DI: B070A77CH0
·
Model: SUT. 4-0 CHROMIC GUT 18"/DS-12
·
Havel's Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HAVEL'S
- Primary DI
- B070A77CH0
- Version / Model
- SUT. 4-0 CHROMIC GUT 18"/DS-12
- Catalog Number
- A77CH
- Company Name
- Havel's Incorporated
- Labeler DUNS
- 101497568
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-16
- Public Version
- 4
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- 36b2df30-73a9-46c9-b316-6a75d7961b60
Device Description
SUTURE 4-0 CHROMIC GUT 18"/DS-12
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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | B070A77CH1 | HIBCC | 12 | In Commercial Distribution | ||
| Primary | B070A77CH0 | HIBCC |
Customer Contacts
- Phone
- 800-638-4770
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K896554 | 000 |