O-RING HEMORRHOID BAND CUTTER
- Primary DI
- B0995085560
- Brand
- O-RING HEMORRHOID BAND CUTTER
- Company
- SONTEC INSTRUMENTS, INC.
- Model
- 508-556
- Device description
- O-RING HEMORRHOID BAND CUTTER
- Published
- 2018-09-06
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| FZT | Cutter, Surgical |
| MDM | Instrument, Manual, Surgical, General Use |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| FZT | Cutter, Surgical | General, Plastic Surgery | 1 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B0995085560 | Previous | HIBCC | 0 | |
| 00192896044753 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00192896044753 | 00192896044753 | 192896044753 | 0192896044753 |
GMDN Terms
| Term | Definition |
|---|
| Surgical instrument seal/seal maintenance set | A seal/collection of seals (e.g., O-rings, shaped or viscous gaskets) intended to be used to replace a damaged sealing component in the maintenance of certain endoscopes, microscopes, injectors, or other surgical instruments. It may include supportive hand tools (screwdrivers). It is not a laparoscopic access cannula seal. |
Device Sizes
| Type | Value | Unit |
|---|
| Length | 6.5 | Inch |
Sterilization Methods
| Method |
|---|
| Dry Heat Sterilization;Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 040729840
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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