FDA UDI
In Commercial Distribution
🇺🇸 United States
GentleGuide
DI: 00850012846697
·
Model: 082030
·
LSI Solutions, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- GentleGuide
- Primary DI
- 00850012846697
- Version / Model
- 082030
- Catalog Number
- 082030
- Company Name
- LSI Solutions, Inc.
- Labeler DUNS
- 603420183
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-11
- Public Version
- 1
- Public Version Date
- 2026-03-19
- Public Version Status
- New
- Public Device Record Key
- d400d75d-bbee-44e0-b512-3eeaaf236010
Device Description
GENTLEGUIDE™ DEVICE
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
- Yes
- 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 |
|---|---|---|---|---|
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63420 | Suture/ligature tightener, single-use | A hand-held manual surgical instrument intended for the in situ tightening of a suture/ligature loop or a suture between a set of suture anchors (not included) during open and/or minimally-invasive surgery (e.g., vascular or gastrointestinal surgery). The suture is intended to be loaded into the device, which typically includes a sliding mechanism or a rigid tube with an internal wire loop for controlled manual tightening; some types may include a non-penetrating fastening device to secure suture ends. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850012846694 | GS1 | Carton | 12 | In Commercial Distribution | |
| Primary | 00850012846697 | GS1 |
Customer Contacts
- Phone
- +1(866)575-3493
- [email protected]