FDA UDI
In Commercial Distribution
🇺🇸 United States
ONETRAC
DI: M648C1001100
·
Model: C100110
·
OBP CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- ONETRAC
- Primary DI
- M648C1001100
- Version / Model
- C100110
- Catalog Number
- C100110
- Company Name
- OBP CORPORATION
- Labeler DUNS
- 011560431
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- b210f573-697c-40f4-918a-b7bb50b46dfc
Device Description
Retractor 135X30mm with Built-In Single-Use Light Source - STERILE
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
- 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 |
|---|---|---|---|---|
| GAD | Retractor | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13375 | Abdominal retractor, hand-held | A surgical instrument designed to be held by the surgeon or assistant to separate the margins of an abdominal incision, typically during deep surgery, to expose or access organs or tissues for examination or intervention. The instrument consists of a blunt-edged, non-adjustable flat blade that curves near the distal tip, with a solid handle at the proximal end. The surgeon or assistant uses this instrument to manually pull the edge of the incision open. It is made of high-grade stainless steel and is available in a variety of blade lengths. This is a reusable device intended to be sterilized prior to use. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M648C1001102 | HIBCC | CASE | 4 | In Commercial Distribution | |
| Package | M648C1001101 | HIBCC | BOX | 10 | In Commercial Distribution | |
| Primary | M648C1001100 | HIBCC |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 45 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 35 Degrees Celsius