FDA UDI
In Commercial Distribution
🇺🇸 United States
REVEEL - Endoscopic Retractor - Trocar
DI: 00811099014416
·
Model: RT083001
·
MICROLINE SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
6
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Basic Information
- Brand Name
- REVEEL - Endoscopic Retractor - Trocar
- Primary DI
- 00811099014416
- Version / Model
- RT083001
- Company Name
- MICROLINE SURGICAL, INC.
- Labeler DUNS
- 184080570
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2025-09-22
- Public Version
- 1
- Public Version Date
- 2025-09-30
- Public Version Status
- New
- Public Device Record Key
- 6356e2b4-d7e4-4a91-a4ef-004a05d33462
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 |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62770 | Hand-held endoscopic retractor, single-use | A hand-held manual surgical instrument intended to be used to enable retraction of tissues during endoscopic/laparoscopic surgery. It consists of a handle with a slender body connected at the distal end to a retracting mechanism (e.g., inflatable/folding paddle, fan-like spreading mechanism, retracting hook). It is intended to be introduced through a laparoscopic port or endoscopic channel; it is not intended for wound retraction or for tissue cutting. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00811099014423 | GS1 | 6 | In Commercial Distribution | ||
| Primary | 00811099014416 | GS1 | ||||
| Unit of Use | 00811099014409 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K133345 | 000 |