FDA UDI
In Commercial Distribution
🇺🇸 United States
REFLEX
DI: 20653405036958
·
Model: 8535
·
Conmed Corporation
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
6
Basic Information
- Brand Name
- REFLEX
- Primary DI
- 20653405036958
- Version / Model
- 8535
- Catalog Number
- 8535
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2020-11-13
- Public Version
- 4
- Public Version Date
- 2022-07-18
- Public Version Status
- Update
- Public Device Record Key
- 6945e014-b60e-48b3-923e-36c522e3e891
Device Description
Reflex One, Skin Stapler, 35 wide
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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FZQ | CLIP, REMOVABLE (SKIN) | General, Plastic Surgery | 878.4320 | 1 |
| QQS | Stapler, skin | General Hospital | 878.4740 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35884 | Skin stapler/staple, non-bioabsorbable | A hand-held manual, surgical instrument preloaded with non-bioabsorbable skin staples designed to apply the staples to approximate the free skin edges of an incision or wound. The staples (which may be clip-like) are made of metal [e.g., stainless steel or titanium (Ti)] and intended to be removed once the wound has sufficiently healed. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10653405036951 | GS1 | BOX | 6 | In Commercial Distribution | |
| Primary | 20653405036958 | GS1 | ||||
| Unit of Use | 00653405036954 | GS1 |
Customer Contacts
- Phone
- +1(866)426-6633
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 32 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 90 Degrees Fahrenheit