NA
- Primary DI
- 04055207045138
- Brand
- NA
- Company
- Richard Wolf GmbH
- Model
- 8991025
- Catalog number
- 8991.025
- Device description
- AMNIOSCOPE TUBE ID 28.7MM OD 32/42MM for adults, TL 140mm, distal end straight, graduated, reusable
- Published
- 2016-09-28
- 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 |
|---|
| HEZ | ENDOSCOPE, TRANSCERVICAL (AMNIOSCOPE)(AND ACCESSORIES) |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HEZ | Endoscope, Transcervical (Amnioscope)(And Accessories) | Obstetrics/Gynecology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 04055207045138 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 04055207045138 | 04055207045138 | 4055207045138 |
GMDN Terms
| Term | Definition |
|---|
| Transcervical amnioscope | An endoscope with a rigid inserted portion intended for the visual examination of the foetus while in the amnion (the thin, tough membrane that lines the chorion and contains the foetus and the amniotic fluid). It is inserted via the vagina, through the maternal uterine cervix and into the amniotic cavity. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This device is typically used to examine the foetus for external malformations, to obtain foetal blood or tissue samples, and for the observation of the colour and volume of amniotic fluid. This is a reusable device. |
Device Sizes
| Type | Value | Unit |
|---|
| Lumen/Inner Diameter | 28.7 | Millimeter |
Sterilization Methods
| Method |
|---|
| Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization |
Contacts
| Phone | Email |
|---|
| +497043350 | info@richard-wolf.com |
Regulatory Flags
- DUNS number
- 315304071
- Device count
- 1
- DM exempt
- true
- 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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