FDA UDI
In Commercial Distribution
🇺🇸 United States
SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ GYN
DI: M648C0100110
·
Model: C010011
·
OBP CORPORATION
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ GYN
- Primary DI
- M648C0100110
- Version / Model
- C010011
- Company Name
- OBP CORPORATION
- Labeler DUNS
- 011560431
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-11
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- c699b963-38c8-47ca-9ea8-51da9715402f
Device Description
C010011 SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ GYN (Customer REF 26153EAU/10)
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
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ODC | Endoscope Channel Accessory | Gastroenterology, Urology | 876.1500 | 2 |
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | 884.1690 | 2 |
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | 884.1720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60650 | Endoscope working-channel seal | A sterile device intended to be fitted over the working channel access port of an endoscope to minimize leakage of liquids and gases through the working channel, while permitting entry of endoscopic devices. It is typically a small plastic Luer attachment with an intraluminal seal. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M648C0100111 | HIBCC | Bag | 10 | In Commercial Distribution | |
| Primary | M648C0100110 | HIBCC |