FDA UDI
Not in Commercial Distribution
🇺🇸 United States
REFLEX
DI: 10653405037101
·
Model: 3031
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
12
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Basic Information
- Brand Name
- REFLEX
- Primary DI
- 10653405037101
- Version / Model
- 3031
- Catalog Number
- 3031
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2020-11-21
- Public Version
- 4
- Public Version Date
- 2026-03-31
- Public Version Status
- Update
- Public Device Record Key
- 18ace8e4-28dd-40f2-8c1f-c21be92d814c
- Distribution End Date
- 2026-03-31
Device Description
REFLEX EXTRACTOR WIDE/REGULAR
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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GDT | STAPLE, REMOVABLE (SKIN) | General, Plastic Surgery | 878.4760 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47192 | Skin staple remover, single-use | A hand-held manual surgical instrument intended to be used to remove skin staples after the healing process has progressed sufficiently to permit the borders of the wound or incision to remain together without assistance. It is a tweezers-like device made of metallic or synthetic polymer materials with blades at the distal end activated by lever action designed for grasping, opening, and removing surgical staples. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20653405037108 | GS1 | BOX | 12 | Not in Commercial Distribution | 2026-03-30 |
| Primary | 10653405037101 | GS1 | ||||
| Unit of Use | 00653405037104 | GS1 |
Customer Contacts
- Phone
- +1(866)426-6633
- [email protected]