FDA UDI
In Commercial Distribution
🇺🇸 United States
3 Ring Suture Passer - 18 cm Bariatric
DI: B354OS3CDB0
·
Model: OS3CDB
·
ORANGE SURGICAL INSTRUMENTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- 3 Ring Suture Passer - 18 cm Bariatric
- Primary DI
- B354OS3CDB0
- Version / Model
- OS3CDB
- Catalog Number
- OS3CDB
- Company Name
- ORANGE SURGICAL INSTRUMENTS, LLC
- Labeler DUNS
- 047063695
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-28
- Public Version
- 4
- Public Version Date
- 2024-01-01
- Public Version Status
- Update
- Public Device Record Key
- fa536b29-03b3-4359-9786-f3b40f8c0a11
Device Description
3 Ring Suture Passer - 18 cm Bariatric
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 |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60390 | Laparoscopic wound closure thread | A sterile, bioabsorbable, implantable, device intended to be used exclusively during laparoscopic surgery to approximate subcutaneous tissue after removal of the laparoscopic sleeve/port. It consists of a suture with an attached short tag (anchor), and often includes a plastic guide which can take different forms depending on the method of laparoscopic entry, and a metal (e.g., stainless steel) and/or plastic pusher. The guide and pusher are used to deliver the suture so that the tag is deep to the wound, with the suture trailing so that it can be ligated on removal of the laparoscopic sleeve/port. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B354OS3CDB0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101733 | 000 |