FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 04715309124932
·
Model: 30-900
·
PANPAC MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 04715309124932
- Version / Model
- 30-900
- Company Name
- PANPAC MEDICAL CORPORATION
- Labeler DUNS
- 657528899
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-15
- Public Version
- 4
- Public Version Date
- 2020-06-25
- Public Version Status
- Update
- Public Device Record Key
- a045f4d6-5d1e-4fcf-a948-da1182797dfa
Device Description
The Pessary Remover is designed for removal of the pessaries easily. It is best used for the removal of the ring, with or without support, the oval, dish, hodge or marland. When using the remover to remove the pessary, it must be used with lubricant.
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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HHF | Remover, Intrauterine Device, Contraceptive, Hook-Type | Obstetrics/Gynecology | 884.4530 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12032 | Intrauterine device removal hook, reusable | A hand-held manual instrument intended to be used by a physician for the extraction of an intrauterine device (IUD). The proximal end forms a handle which may vary in shape and which tapers toward the distal end to form a hook. It is typically made of high-grade stainless steel. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04715309124970 | GS1 | BOX | 25 | In Commercial Distribution | |
| Primary | 04715309124932 | GS1 |
Customer Contacts
- Phone
- +866286472242
- [email protected]