FDA UDI
In Commercial Distribution
🇺🇸 United States
ORC TYPE XL-11
DI: 00858690006327
·
Model: 18 GA x 11"
·
RANFAC CORP.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ORC TYPE XL-11
- Primary DI
- 00858690006327
- Version / Model
- 18 GA x 11"
- Catalog Number
- XL-11
- Company Name
- RANFAC CORP.
- Labeler DUNS
- 121622872
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-04
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- b61c32b2-55f1-445e-8b49-224a92ce920d
Device Description
LAPAROSCOPIC CHOLANGIOGRAPHY CTHTR-11 ORC TYPE XL-11 PN 68012-01M
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
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GBZ | Catheter, Cholangiography | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41976 | Rigid endoscopic cannula, single-use | A sterile, rigid, single-lumen device intended to be used during endoscopy to provide cannulation for the instillation or aspiration of fluid to/from a targeted area of the body (e.g., introduction of drug solutions, a contrast medium or other kinds of fluid/solution into a body cavity for diagnosis and treatment) or for the introduction/accommodation of another device. It will typically be made of high-grade stainless steel and/or other durable materials. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20858690006321 | GS1 | Case | 6 | In Commercial Distribution | |
| Package | 10858690006324 | GS1 | Inner Pack | 10 | In Commercial Distribution | |
| Primary | 00858690006327 | GS1 |
Customer Contacts
- Phone
- 5085884400
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 11 | Inch | |
| Needle Gauge | 18 | Gauge |