FDA UDI
In Commercial Distribution
🇺🇸 United States
SOLAR Anorectal Manometry Charger
DI: 00627825014823
·
Model: ZM12-AC59-2213
·
Laborie Medical Technologies Corp.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SOLAR Anorectal Manometry Charger
- Primary DI
- 00627825014823
- Version / Model
- ZM12-AC59-2213
- Company Name
- Laborie Medical Technologies Corp.
- Labeler DUNS
- 117783313
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-06
- Public Version
- 1
- Public Version Date
- 2025-03-14
- Public Version Status
- New
- Public Device Record Key
- 773e4e6e-e1f4-4b34-95bb-7fd196db32b6
Device Description
SOLAR Anorectal Manometry Charger
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KLA | Monitor, Esophageal Motility, Anorectal Motility, And Tube | Gastroenterology, Urology | 876.1725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62242 | Gastrointestinal motility manometric catheter, electronic | A flexible tube with electronic sensors at the distal end intended to be inserted through the nose or rectum into the gastrointestinal (GI) tract to evaluate peristaltic motility anywhere in the GI tract (pharynx, oesophagus, stomach, duodenum, small bowel, colon, and anorectal area) by measuring pressure; it may additionally be intended to measure pH and electrical impedance and contain a lumen. Also known as a GI solid-state sensor catheter, it is intended for proximal connection to an appropriate gastrointestinal motility analysis system, and the acquired data may be used to generate a 3-D image. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00627825014823 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K234107 | 000 |