FDA UDI
In Commercial Distribution
🇺🇸 United States
Axiom® Lig-A-Loops®
DI: M6651160
·
Model: 116
·
AXIOM MEDICAL, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- Axiom® Lig-A-Loops®
- Primary DI
- M6651160
- Version / Model
- 116
- Company Name
- AXIOM MEDICAL, INCORPORATED
- Labeler DUNS
- 094439676
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-23
- Public Version
- 2
- Public Version Date
- 2019-09-10
- Public Version Status
- Update
- Public Device Record Key
- 15ef0baa-541b-4f79-97a0-230b73a06c83
Device Description
Retraction Tape, Mini, Yellow, Ureters
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 |
|---|---|---|---|---|
| KDC | Instrument, Surgical, Disposable | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46242 | Surgical support tape, non-bioabsorbable | A band or cord intended to be used during surgery for the approximation, cerclage, fixation, retraction, ligation, and/or suspension of internal anatomical structures; some types may be used for connecting and supporting bone and/or ligaments and tendons. The device is typically made of a synthetic material (e.g., polyester, nylon, silicone) or cotton, is available in a variety of lengths and widths, and may be left in situ. This is a device that cannot be chemically degraded or absorbed via natural body processes. Disposable devices associated with implantation may be included. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M6651165 | HIBCC | Carton | 60 | In Commercial Distribution | |
| Package | M6651163 | HIBCC | Case | 10 | In Commercial Distribution | |
| Package | M6651161 | HIBCC | Box | 10 | In Commercial Distribution | |
| Primary | M6651160 | HIBCC |
Customer Contacts
- Phone
- 310-533-9020
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K800015 | 000 |